Medical tube apparatus

ABSTRACT

An endotracheal tube apparatus comprising an endotracheal tube and a hub connection fitting connected with the endotracheal tube. The endotracheal tube is configured to be inserted into a trachea of human body. A ventilation passageway is within the hub connection fitting and along a length of the endotracheal tube. The hub connection fitting may include a power source and a light emitting device. The hub connection fitting may also include a sensor apparatus configured to detect one or more respiration gases of the human body, wherein the sensor apparatus is powered by the power source.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT patent application no.PCT/US2015/011818 filed Jan. 16, 2015, which claims the benefit of U.S.provisional patent application Ser. No. 61/928,685 filed Jan. 17, 2014,the entire disclosures of which are incorporated herein by reference.This application also claims the benefit of U.S. provisional patentapplication Ser. No. 62/151,899 filed Apr. 23, 2015 and U.S. provisionalpatent application Ser. No. 62/195,577 filed Jul. 22, 2015, the entiredisclosures of which are incorporated herein by reference.

FIELD

This disclosure relates generally to the field of medical devices, andmore specifically to a medical tube apparatus and, in certainembodiments, an endotracheal tube apparatus to be used on a human body.

BACKGROUND

Artificial respiration involves assisting or stimulating a person'snatural respiration, a metabolic process referring to an exchange ofgases within the body by pulmonary ventilation, external respiration andinternal respiration. Pulmonary ventilation is achieved throughinsufflation (e.g. manual or automated) of a person's lungs by causingair or oxygen to flow in and out of a person's lungs, generally whennatural breathing has stopped or is otherwise inadequate.

One method of pulmonary ventilation involves intubation, or entubation,which pertains to the insertion of a tube generally into an externalorifice of the body. One particular method of intubation is trachealintubation, in which a flexible plastic tube is inserted into thetrachea (windpipe) of a person to provide or maintain an open airway,and to serve as a conduit through which to administer certain drugs viaa drug delivery port. Tracheal intubation is often performed incritically injured or anesthetized patients to facilitate pulmonaryventilation and to prevent the possibility of asphyxiation or airwayobstruction. Tracheal intubation is most often orotracheal, in which anendotracheal tube is passed through the mouth and voice box (vocalcords) of a person and into the trachea.

During an endotracheal intubation, the person's mouth is opened and theendotracheal tube is inserted down the throat. To better ensure theendotracheal tube is properly positioned, a laryngoscope may be used tobring the vocal cords and larynx into view prior to inserting theendotracheal tube. The tube may then be inserted in the trachea throughthe vocal cords to the point that an inflation cuff surrounding a distalend portion of the tube rests just below the vocal cords. Finally, afteran inflation cuff is inflated to inhibit leakage, a bag valve mask issqueezed adjacent a proximal end of the tube to pass air and/or oxygento the lungs. A stethoscope may then be used by medical personnel tolisten for breathing sounds to ensure proper placement of the tube.

Often endotracheal intubation must be performed away from a clinic andin the field, particularly during a trauma and other emergencysituations. Unfortunately, under such adverse conditions, it may not bepossible to use a laryngoscope or a stethoscope to ensure properplacement of the endotracheal tube in the trachea, in which case theendotracheal tube may enter the esophagus.

As a result, in addition to a drug delivery port and a cuff inflationport, the endotracheal tube generally includes a sampling port, providedas part of a separate adapter to be connected to the connector of theendotracheal tube, to sample gases of the person being intubated. Moreparticularly, the sampling port may be a carbon dioxide sampling portwhich is connectable to a carbon dioxide analyzer/monitor (e.g. acapnograph). However, it may be appreciated that in the field such ananalyzer/monitor may not always be available for use.

With endotracheal tubes prior to the present disclosure, the drugdelivery port and the cuff inflation port include tubing which isspliced from the outside into a side wall of the endotracheal tube.Unfortunately, because the spliced tubing is located between theendotracheal tube and the person's mouth during use, the tubing segmentsof the ports may be damaged during use, such as being severed by theperson's teeth in response to a seizure. Also, the spliced ports maybecome compressed between the person's mouth and the endotracheal tube,and not function as intended.

What is needed is a tube apparatus, particularly such as an endotrachealtube apparatus, which incorporates various ports which are lesssusceptible to damage during use of the endotracheal tube. What is alsoneeded is a tube apparatus, such as an endotracheal tube apparatus,which provides visual aid to better ensure proper placement of theendotracheal tube in the trachea. What is also needed is a tubeapparatus, such as an endotracheal tube apparatus, which may incorporateone or more sensors, such as to detect one or more physiologicalparameters applicable to the health state of a person (e.g. detect oneor more gases being exhaled by a person (e.g. carbon dioxide) or bodytemperature). In such a manner, reliance on additional (separate)(equipment which is not always available, particular in the field, maybe reduced or eliminated.

SUMMARY

The present disclosure provides medical devices comprising a tubeapparatus, which may particularly be an endotracheal tube apparatus, ofa medical (respiratory) system. The tube apparatus, such as anendotracheal tube apparatus, may incorporate one or more ports which areless susceptible to damage by a patient during use of the endotrachealtube by virtue of the one or more ports not being spliced into the sidewall of the endotracheal tube. The tube apparatus, such as anendotracheal tube apparatus, may also incorporate a lighting apparatusto provide visual aid during endotracheal intubation to better ensureproper placement of the endotracheal tube in the trachea. The tubeapparatus, such as an endotracheal apparatus, may also incorporate asensor apparatus to detect one or more physiological parametersapplicable to the health state of a patient to reduce or eliminatereliance on additional (separate) equipment to perform such detection.

In addition to the foregoing benefits, the medical devices comprising atube apparatus, and more particularly an endotracheal tube apparatus, ofa medical (respiratory) system according to the present disclosure, mayreduce stack-up of multiple components and associated air leaksoccurring there between by combining multiple features into a hubconnection fitting of the endotracheal tube apparatus.

In certain embodiments, the present disclosure provides a medical devicecomprising a tube apparatus including a tube and a hub connectionfitting; the tube insertable into a patient; the hub connection fittingconnectable to the tube; a central passageway extending through the hubconnection fitting and longitudinally with the tube; a plurality ofports joined with the hub connection fitting, the plurality of portscomprising at least a first port and a second port; wherein the firstport is operable with a first port passageway, wherein the first portpassageway extends through the hub connection fitting and longitudinallywith the tube; and wherein the second port is operable with a secondport passageway, wherein the second port passageway extends through thehub connection fitting and longitudinally with the tube.

With the tube apparatus, the passageways for the ports are contained inthe tube and the hub connection fitting, thus inhibiting a risk that theports may become damaged once positioned within the trachea of apatient.

In certain embodiments, the present disclosure also provides a medicaldevice comprising an endotracheal tube apparatus including anendotracheal tube and a hub connection fitting; the endotracheal tubeinsertable into a trachea of a patient; the hub connection fittingconnectable to the endotracheal tube; a ventilation passageway extendingthrough the hub connection fitting and along a length of theendotracheal tube; and a plurality of ports joined with the hubconnection fitting. The plurality of ports may comprise at least onefluid sampling port and at least one drug delivery port; wherein thefluid sampling port is operable with a fluid sampling passageway,wherein the fluid sampling passageway extends through the hub connectionfitting and through a fluid sampling lumen of the endotracheal tube andwherein the drug delivery port is operable with a drug deliverypassageway, wherein the drug delivery passageway extends through the hubconnection fitting and through a drug delivery lumen of the endotrachealtube. In certain embodiments, the plurality of ports may furthercomprise at least one cuff inflation port or an additional drug deliveryport. The cuff inflation port may be present for adult devices, andremoved for pediatric or neonatal devices.

In certain embodiments, the fluid sampling passageway extends through afluid sampling port tubing segment which connects the fluid samplingport to the hub connection fitting; and the drug delivery passagewayextends through a drug delivery port tubing segment which connects thedrug delivery port to the hub connection fitting.

In certain embodiments, the fluid sampling port tubing segment islocated in a first counterbore of the hub connection fitting; and thedrug delivery port tubing segment is located in a second counterbore ofthe hub connection fitting.

In certain embodiments, at least one of the fluid sampling port tubingsegment and the drug delivery port tubing segment is at least one ofinterference fit, adhesively bonded and welded to the hub connectionfitting.

In certain embodiments, the fluid sampling port includes a fluidsampling port connector to connect the fluid sampling port to ananalyzer to detect a presence of carbon dioxide gas in a fluid samplecomprising one or more gases exhales from the patient.

In certain embodiments, the hub connection fitting comprises a fluidsampling passageway connector which connects with the fluid samplingpassageway of the endotracheal tube; and a drug delivery passagewayconnector which connects with the drug delivery passageway of theendotracheal tube.

In certain embodiments, the fluid sampling passageway connectorcomprises a male connector portion which is located in a fluid samplinglumen of the endotracheal tube which provides the fluid samplingpassageway of the endotracheal tube; and the drug delivery passagewayconnector comprises a male connector portion which is located in a drugdelivery lumen of the endotracheal tube which provides the drug deliverypassageway of the endotracheal tube.

In certain embodiments, the fluid sampling passageway connector is atleast one of interference fit, adhesively bonded and welded within thefluid sampling lumen of the endotracheal tube; and the drug deliverypassageway connector is at least one of interference fit, adhesivelybonded and welded within the drug delivery lumen of the endotrachealtube.

In certain embodiments, the plurality of ports further comprise at leastone cuff inflation port; and wherein the cuff inflation port in operablewith a cuff inflation passageway, wherein the cuff inflation passagewayextends through the hub connection fitting and through a cuff inflationlumen of the endotracheal tube.

In certain embodiments, the cuff inflation passageway extends through acuff inflation port tubing segment which connects the cuff inflationport to the hub connection fitting;

In certain embodiments, the cuff inflation port tubing segment islocated in a counterbore of the hub connection fitting.

In certain embodiments, the cuff inflation port tubing segment is atleast one of interference fit, adhesively bonded and welded to the hubconnection fitting.

In certain embodiments, the hub connection fitting comprises a cuffinflation passageway connector which connects with the cuff inflationpassageway of the endotracheal tube.

In certain embodiments, the cuff inflation passageway connectorcomprises a male connector portion which is located in a cuff inflationlumen of the endotracheal tube which provides the cuff inflationpassageway of the endotracheal tube.

In certain embodiments, the cuff inflation passageway is at least one ofinterference fit, adhesively bonded and welded within the cuff inflationlumen of the endotracheal tube.

In certain embodiments, the hub connection fitting includes cylindricalconnector portion adapted to be inserted into a respirator tube of arespirator means.

In certain embodiments, the medical device further comprises a lightingapparatus. The lighting apparatus may comprise a light source and abattery.

In certain embodiments, the medical device further comprises a camera.

In certain embodiments, the present disclosure also provides a medicaldevice comprising an endotracheal tube apparatus including anendotracheal tube and a hub connection fitting; the endotracheal tubeinsertable into a trachea of a patient; the hub connection fittingconnectable to the endotracheal tube; a ventilation passageway extendingthrough the hub connection fitting and along a length of theendotracheal tube; and a plurality of ports joined with the hubconnection fitting. The plurality of ports may comprise at least onefluid sampling port, at least one drug delivery port, and at least onecuff inflation port; wherein the fluid sampling port is operable with afluid sampling passageway, wherein the fluid sampling passageway extendsthrough the hub connection fitting and through a fluid sampling lumen ofthe endotracheal tube; wherein the drug delivery port is operable with adrug delivery passageway, wherein the drug delivery passageway extendsthrough the hub connection fitting and through a drug delivery lumen ofthe endotracheal tube; and wherein the cuff inflation port in operablewith a cuff inflation passageway, wherein the cuff inflation passagewayextends through the hub connection fitting and through a cuff inflationlumen of the endotracheal tube.

In certain embodiments, the present disclosure also provides a method offorming a medical device comprising: providing an elongated tube havinga plurality of lumens; providing a hub connection fitting including aplurality of male connectors; connecting the hub connection fitting andthe tube such that each male connector of the plurality of maleconnectors is inserted into and occupies a different lumen of theplurality of lumens of the tube; wherein the plurality of lumenscomprise at least a central lumen; a first secondary lumen and a secondsecondary lumen; wherein, upon connecting the hub connection fitting andthe tube, a central passageway is formed which extends through the hubconnection fitting and longitudinally through the central lumen of thetube; a first port passageway is formed which extends through the hubconnection fitting and longitudinally through the first secondary lumenof the tube; and a second port passageway is formed which extendsthrough the hub connection fitting and longitudinally through the secondsecondary lumen of the tube.

In certain embodiments, the present disclosure provides a medical devicecomprising an endotracheal tube apparatus including an endotracheal tubeand a hub connection fitting; the endotracheal tube insertable into atrachea of a patient; the hub connection fitting connectable to theendotracheal tube; a ventilation passageway extending through the hubconnection fitting and along a length of the endotracheal tube; and thehub connection fitting including a light emitting device.

In certain embodiments, the hub connection fitting contains the lightemitting device.

In certain embodiments, the hub connection fitting comprises a hubconnection fitting body; the light emitting device comprises alight-source module; and the light source module is contained in the hubconnection fitting body.

In certain embodiments, the light source module comprises at least onelight-emitting diode mounted to a printed circuit board, and a battery.

In certain embodiments, the light source module comprises a removablenon-conductive liner which is arranged to inhibit a formation of anelectrical connection between the at least one light emitting diode andthe battery.

In certain embodiments, the light source module comprises a housingwhich contains the battery, the printed circuit board and the removablenon-conductive liner.

In certain embodiments, a second passageway extends along the length ofthe endotracheal tube parallel with the ventilation passageway; and thelight-emitting device is arranged to direct light down the secondpassageway.

In certain embodiments, the light-emitting device comprises a tubularlight guide; and the second passageway contains the tubular light guide.

In certain embodiments, the light-emitting device comprises a lightsource; the hub connection fitting includes the light source of thelight emitting device; and the light source and the tubular light guideare arranged such that the light source provides light along a length ofthe tubular light guide.

In certain embodiments, the light source and the tubular light guide arearranged such that the light source provides light into the tubularlight guide without being reflected.

In certain embodiments, the light source and the tubular light guide arearranged such that the light source provides light into the tubularlight guide after the light has been reflected.

In certain embodiments, the light source and the tubular light guide arearranged such that the light source provides light into the tubularlight guide after the light has been reflected 90 degrees.

In certain embodiments, the second passageway is defined by a side wall;and when the endotracheal tube is bent, at least a portion of thetubular light guide is slidable along the side wall.

In certain embodiments, the second passageway is at least one of a fluidsampling passageway, a drug delivery passageway; and a cuff inflationpassageway.

In certain embodiments, at least one of a fluid sampling port, a drugdelivery port and a cuff inflation port joined with the hub connectionfitting; and the at least one of a fluid sampling port, a drug deliveryport and a cuff inflation port is operable with the second passageway.

In certain embodiments, the secondary passageway is a cuff inflationpassageway; the at least one of a fluid sampling port, a drug deliveryport and a cuff inflation port joined with the hub connection fitting isa cuff inflation port joined with the hub connection fitting; and thecuff inflation port is operable with the cuff inflation passageway.

In certain embodiments, the present disclosure provides a medical devicecomprising an endotracheal tube apparatus including an endotracheal tubeand a hub connection fitting; the endotracheal tube insertable into atrachea of a patient; the hub connection fitting connectable to theendotracheal tube; a ventilation passageway extending through the hubconnection fitting and along a length of the endotracheal tube; asecondary passageway within the ventilation passageway arranged suchthat the secondary passageway is in fluid communication with theventilation passageway; and the secondary passageway having a side wallformed unitarily with a sidewall of the ventilation passageway as asingle piece monolithic structure.

In certain embodiments, the hub connection fitting is formed ofthermoplastic, such as polyethylene, polypropylene, polyamide orpolyacetal, by injection molding.

In certain embodiments, the present disclosure provides a medical devicecomprising an endotracheal tube apparatus including an endotracheal tubeand a hub connection fitting; the endotracheal tube insertable into atrachea of a patient; the hub connection fitting connectable to theendotracheal tube; a ventilation passageway extending through the hubconnection fitting and along a length of the endotracheal tube; and thehub connection fitting including a sensor apparatus configured to detectone or more respiration gases of the patient.

In certain embodiments, the hub connection fitting contains the sensorapparatus.

In certain embodiments, the hub connection fitting comprises a hubconnection fitting body; the sensor apparatus comprises a sensor module;and the sensor module is contained in the hub connection fitting body.

In certain embodiments, the sensor module comprises a printed circuitboard and a battery.

In certain embodiments, the sensor module comprises a removablenon-conductive liner which is arranged to inhibit a formation of anelectrical connection.

In certain embodiments, the sensor module comprises a housing whichcontains the battery, the printed circuit board and the removablenon-conductive liner.

In certain embodiments, the sensor apparatus comprises a sensor, such asa carbon dioxide sensor.

In certain embodiments, the sensor comprises a capnography sensor, aspectroscopic sensor, a light sensor and/or an infrared sensor.

In certain embodiments, the sensor comprises a light emitter and a lightdetector.

In certain embodiments, the hub connection fitting comprises at leastone of a processor, a computer readable storage medium, a communicationelement, and an output display which each operate with the sensor.

In certain embodiments, the communication element comprises at least oneof a transmitter and a receiver.

In certain embodiments, the output display comprises at least one of aliquid crystal display, a light-emitting diode, a gas plasma display anda cathode ray tube.

In certain embodiments, the sensor apparatus is configured to wirelesslycommunicate with at least one remote electronic device.

In certain embodiments, the senor apparatus is configured to wirelesslycommunicate with the at least one remote electronic device on a network.

In certain embodiments, the at least one remote electronic devicecomprises at least one of a desktop computer, a portable computer, alaptop computer, a notebook computer, a netbook computer, a personaldigital assistant computer, a wearable computer, a phone computer orhandheld computer.

In certain embodiments, the sensor apparatus comprises a sensor; and atleast one of the sensor apparatus and the at least one remote electronicdevice is configured to convert a signal from the sensor to an exhaledgas concentration value by an algorithm.

In certain embodiments, at least one of the sensor apparatus and the atleast one remote electronic device is configured to output a visualrepresentation of the exhaled gas concentration value to an outputdisplay.

FIGURES

The above-mentioned and other features of this disclosure, and themanner of attaining them, will become more apparent and betterunderstood by reference to the following description of embodimentsdescribed herein taken in conjunction with the accompanying drawings,wherein:

FIG. 1 is a side view of a medical system including a medical devicecomprising a tube apparatus, and more particularly an endotracheal tubeapparatus, according to the present disclosure;

FIG. 1A is an enlarged distal end view of the endotracheal tubeapparatus of FIG. 1;

FIG. 1B is an enlarged distal end view of another embodiment of theendotracheal tube apparatus;

FIG. 2 is an exploded longitudinal cross-sectional side view of theendotracheal tube apparatus of FIG. 1;

FIG. 2A is an exploded longitudinal cross-sectional side view of anotherembodiment of the endotracheal tube apparatus;

FIG. 3 is a longitudinal cross-sectional perspective view of a hubconnection fitting of the endotracheal tube apparatus of FIG. 1;

FIG. 4 is a top view of the hub connection fitting of the endotrachealtube apparatus of FIG. 1;

FIG. 5 is a bottom view of the hub connection fitting of theendotracheal tube apparatus of FIG. 1;

FIG. 6 is a side view of the endotracheal tube apparatus of FIG. 1including other devices for use therewith;

FIG. 7 is an exploded longitudinal cross-sectional side view of anotherembodiment of the endotracheal tube apparatus;

FIG. 8 is a perspective view of another embodiment of the endotrachealtube apparatus;

FIG. 9 is an exploded view of a hub connection fitting of theendotracheal tube apparatus of FIG. 8;

FIG. 10 is an exploded cross-sectional side view of a light sourcemodule of the hub connection fitting of the endotracheal tube apparatusof FIG. 8;

FIG. 11 is longitudinal cross-sectional perspective view of theendotracheal tube apparatus of FIG. 8;

FIG. 12 is a first longitudinal cross-sectional side view of theendotracheal tube apparatus of FIG. 8;

FIG. 13 is a second longitudinal cross-sectional side view of theendotracheal tube apparatus of FIG. 8;

FIG. 13A is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 13B is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 13C is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 13D is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 13E is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 13F is a longitudinal cross-sectional side view of a distal endregion of another embodiment of the endotracheal tube apparatus;

FIG. 14 is a longitudinal cross-sectional side view of anotherembodiment of the endotracheal tube apparatus;

FIG. 15 is a longitudinal cross-sectional side view of anotherembodiment of the endotracheal tube apparatus;

FIG. 16 is a longitudinal cross-sectional side view of anotherembodiment of the endotracheal tube apparatus;

FIG. 17 is an exploded cross-sectional side view of a sensor module ofthe hub connection fitting of the endotracheal tube apparatus of FIG.16;

FIG. 18 is a top view of a sensor module according to another embodimentof the endotracheal tube apparatus;

FIG. 19 is top view of a sensor module according to another embodimentof the endotracheal tube apparatus;

FIG. 20A is a perspective view of another embodiment of the endotrachealtube apparatus;

FIG. 20B is a first side view of the endotracheal tube apparatus of FIG.20A;

FIG. 20C is a second side view of the endotracheal tube apparatus ofFIG. 20A;

FIG. 20D is a longitudinal cross sectional side view of the endotrachealtube apparatus of FIG. 20A taken along line 20D-20D of FIG. 20C;

FIG. 21A is a top perspective view of a hub connection fitting of theendotracheal tube apparatus of FIG. 20A;

FIG. 21B is a bottom perspective view of the hub connection fitting ofFIG. 20A;

FIG. 21C is a top view of the hub connection fitting of FIG. 20A;

FIG. 21D is a bottom view of the hub connection fitting of FIG. 20A;

FIG. 21E is a longitudinal cross sectional side view of the hubconnection fitting of FIG. 20A taken along line 21E-21E of FIG. 20C;

FIG. 21F is a transverse cross sectional view of the hub connectionfitting of FIG. 20A taken along line 21F-21F of FIG. 21E;

FIG. 21G is a transverse cross sectional view of the hub connectionfitting of FIG. 20A taken along line 21G-21G of FIG. 21E;

FIG. 21H is a transverse cross sectional view of the hub connectionfitting of FIG. 20A taken along line 21H-21H of FIG. 21E;

FIG. 21I is a transverse cross sectional view of the hub connectionfitting of FIG. 20A taken along line 21I-21I of FIG. 21E;

FIG. 22A is a side view of an endotracheal tube of the endotracheal tubeapparatus of FIG. 20A;

FIG. 22B is a longitudinal cross-sectional side view of the endotrachealtube of FIG. 22A taken along line 22B-22B of FIG. 22A;

FIG. 23A is an assembled perspective view of a lighting device of alight source module of the hub connection fitting of FIG. 20A;

FIG. 23B is a top view of the lighting device of FIG. 23A;

FIG. 23C is a first side view of the lighting device of FIG. 23A;

FIG. 23D is a second side view of the lighting device of FIG. 23A;

FIG. 24A is a first side view of a housing for the lighting device forthe light source module of FIG. 23A;

FIG. 24B is a cross sectional side view of the housing of FIG. 24A takenalong line 24B-24B of FIG. 24A;

FIG. 25A is a top view of an endotracheal tube connector of the hubconnection fitting of FIG. 20A; and

FIG. 25B is a longitudinal cross-sectional side view of the endotrachealtube connector of FIG. 25A taken along line 25B-25B of FIG. 25A.

DETAILED DESCRIPTION

It may be appreciated that the present disclosure is not limited in itsapplication to the details of construction and the arrangement ofcomponents set forth in the following description or illustrated in thedrawings. The invention(s) herein may be capable of other embodimentsand of being practiced or being carried out in various ways. Also, itmay be appreciated that the phraseology and terminology used herein isfor the purpose of description and should not be regarded as limiting assuch may be understood by one of skill in the art. Furthermore,throughout the present description, like reference numerals and lettersindicate corresponding structure throughout the several views, and suchcorresponding structure need not be separately discussed. Furthermore,any particular feature(s) of a particular exemplary embodiment may beequally applied to any other exemplary embodiment(s) of this disclosureas suitable. In other words, features between the various exemplaryembodiments described herein are interchangeable as suitable, and notexclusive.

Referring now to FIGS. 1-5, there is shown a medical device 10comprising a tube apparatus 20, and more particularly an endotrachealtube apparatus 20 of a medical (respiratory) system 2 according to thepresent disclosure. While a remainder of the disclosure may refer to thetube apparatus as being an endotracheal tube apparatus 20, particularlyfor single-use (disposable) applications, it should be understood thatthe present disclosure is not limited to an endotracheal tube apparatus20, and the present tube apparatus may have other medical applications,as well as non-medical applications, other than that of endotrachealtube apparatus 20. While endotracheal tube apparatus 20 may be describedherein for oral intubation, apparatus 20 may also be used for trachealintubation (e.g. cricothyrotomy tube, tracheostomy tube) and nasalintubation.

As shown, the endotracheal tube apparatus 20 comprises a flexible,elongated, hollow endotracheal tube 30, which may be extruded(thermoplastic) tubing having a constant profile along its length, to beinserted into the trachea of a human host, such as a patient. Exemplarythermoplastic polymer compositions may include plasticized polyvinylchloride and thermoplastic elastomers. As such, in certain embodiments,the endotracheal tube 30 may have a length in a range of 7.5 cm to 50 cm(including all ranges and increments there between); and moreparticularly in a range of 17 cm to 23 cm (including all ranges andincrements there between). As shown, endotracheal tube 30 iscylindrical, with a constant diameter, however in other embodimentsendotracheal tube 30 may not necessarily be cylindrical or have aconstant diameter.

Endotracheal tube 30 is preferably light transmissive to visible lightand substantially transparent. As used herein, substantially transparentmay be understood as providing integral transmission of at least 60% ofincident light in the visible spectrum (about 400-700 nm wavelength),and more preferably at least 70% of incident light in the visiblespectrum, and even more preferably, at least 80% or moreover at least90% of incident light in the visible spectrum. Also, substantiallytransparent may be understood to include translucent in accordance withthe above.

As used herein, an elastomer may be characterized as a material that hasan elongation at 23° C. of at least 100%, and which, after beingstretched to twice its original length and being held at such for oneminute, may recover in a range of 50% to 100% within one minute afterrelease from the stress. More particularly, the elastomer may recover ina range of 75% to 100% within one minute after release from the stress,and even more particularly recover in a range of 90% to 100% within oneminute after release from the stress. The elastomer may be comprised ofany polymer, including natural or synthetic polymers, and thermoplasticor thermoset polymers. Thus, the elastomer may be either a natural orsynthetic elastomer. The elastomer may comprise, essentially consist ofor consist of natural or synthetic rubber.

Endotracheal tube 30 has an outer cylindrical side wall 32 having anouter surface 34 an inner surface 36. In certain embodiments, theendotracheal tube 30 may have an outer diameter OD in a range of 5 mm to15 mm (including all ranges and increments there between), and moreparticularly in a range of 9 mm to 13 mm (including all ranges andincrements there between). The thickness of the outer cylindrical sidewall 32 may be in a range from 0.75 mm to 3 mm (including all ranges andincrements there between) and more particularly in a range of 1 mm to 2mm (including all ranges and increments there between).

Endotracheal tube 30 includes a centrally disposed ventilationpassageway 38, in the form of a lumen, which extends along the length ofthe endotracheal tube 30 from a proximal end opening 40 of theendotracheal tube 30 to a distal end opening 42 of the endotracheal tube30. As shown, the ventilation passageway 38 shares a common longitudinal(center) axis 41 with the endotracheal tube 30. Ventilation passageway38 may be understood as the primary passageway for tracheal intubationand subsequent use of a respirator apparatus 500, such as a bag valvemask or a mechanical ventilator as known in the art connected toendotracheal tube apparatus 20 to provide mechanicalventilation/respiration to the patient.

Respirator apparatus 500 may also include an impedance threshold device(ITD) as known in the art that selectively prevents unnecessary air fromenter the chest/lungs of a patient during the chest wall recoil phase ofcardiopulmonary resuscitation (CPR). The ITD may be used in conjunctionwith the bag valve mask as known in the art. Use of the ITD deviceresults in greater vacuum (negative pressure) in the chest/lungs duringthe chest wall recoil phase. An exemplary ITD is the ResQPOD impedancethreshold device. The ITD maintains lower airway pressure and reducesthe pressure inside the patient's chest. This reduced pressure drawsmore blood back to the heart during the decompression phase of CPR. As aresult, a greater volume of blood may flow out of the heart during thenext compression, which may improve overall blood circulation ascompared to standard CPR.

The maximum inner diameter ID of the ventilation passageway 38 may be ina range of 3 mm to 13 mm (including all ranges and increments therebetween), and more particularly in a range of 7 mm to 11 mm (includingall ranges and increments there between).

In addition, endotracheal tube 30 includes a plurality of secondarypassageways 44, 46 and 48, all provided by lumens, which have (semi)cylindrical side walls 54, 56 and 58 which are formed unitary (i.e.formed as a single piece monolithic) with the outer cylindrical sidewall 32, with the cylindrical side walls 54, 56 and 58. As shown, thesemi cylindrical side walls 54, 56 and 58 have a circumference whichextends over an arc of approximately 200 degrees. However, thecircumference of the arc may range from, for example, 180 degrees to 330degrees (including all ranges and increments there between), and moreparticularly 200 degrees to 300 degrees (including all ranges andincrements there between). While all the secondary passageways 44, 46and 48 are shown to have the same cross-sectional profile (circular) andsize, they may have different profiles and sizes.

As shown, the secondary passageways 44, 46 and 48 may be arranged 90degrees apart from one another on the outer cylindrical side wall 32 andextend parallel with ventilation passageway 38 in endotracheal tube 30.As shown, all of the ventilation passageway 38 and the secondarypassageways 44, 46 and 48 have a different longitudinal axis (i.e. noneof the ventilation passageway 38 and secondary passageways 44, 46 and 48are coaxial), and the axis of secondary passageways 44, 46 and 48 areparallel with the axis of ventilation passageway 38. Cylindrical sidewalls 54, 56 and 58 may have a thickness in a range from 0.5 mm to 2 mm(including all ranges and increments there between) and moreparticularly in a range of 0.75 mm to 1.5 mm (including all ranges andincrements there between).

As shown in FIG. 1A, in certain embodiments the secondary passageways44, 46 and 48 may not be formed within the outer cylindrical side wall32, but rather adjacent thereto, as placing the secondary passageways44, 46 and 48 within the confines of the outer cylindrical side wall 32may locally weaken the outer cylindrical side wall 32. Furthermore, asthe proximal end of the endotracheal tube 30 seals with a hub connectionfitting 70 as further described herein, maintaining the thickness ofouter cylindrical side wall 32 uniformly around the ventilationpassageway 38 may provide a more stable seal. In such case, as shown,the secondary passageways 44, 46, 48 and the inner walls thereof 54, 56,58 thereof will narrow the ventilation passageway 38 in certainlocations along the length of the ventilation passageway 38 in the formof a semi-circular/semi-cylindrical protuberance into the ventilationpassageway 38.

However, in certain embodiments, as shown in FIG. 1B, one or more of thesecondary passageways 44, 46 and 48 may reduce the thickness of theouter cylindrical side wall 32 (shown at location 32 a) to no less than60% (and preferably no less than 70% and more preferably no less than80% and even more preferably no less than 90%) of the thickness of theouter cylinder side wall 32 adjacent to the secondary passageways 44, 46and 48 (shown at location 32 b) located between the secondarypassageways 46 and 48.

As explained in greater detail below, secondary passageway 44 is a fluidsampling passageway in fluid communication with a fluid sampling port 24of the endotracheal tube apparatus 20, while secondary passageway 46 isa drug delivery passageway in fluid communication with a drug deliveryport 26 and secondary passageway 48 is a cuff inflation passageway influid communication with a cuff inflation port 28. As shown, the overallinner diameter and radius of the secondary passageways 44, 46, 48 issmaller than the overall inner diameter and radius of the ventilationpassageway 38, and in a range of 10%-50% of the inner diameter andradius of the ventilation passageway 38 (including all ranges andincrements there between) and more particularly in a range of 20%-40%(including all ranges and increments there between) of the innerdiameter and radius of the ventilation passageway 38, such as 25-35% ofthe inner diameter and radius of the ventilation passageway 38(including all ranges and increments there between).

In addition to endotracheal tube 30, endotracheal apparatus 20 furthercomprises hub connection fitting 70 that operatively connects theendotracheal tube 30 to respirator apparatus 500. The hub connectionfitting 70 comprises a (main) body 72, which may be formed of injectionmolded thermoplastic, such as polypropylene, polyethylene, polyamide andpolyacetal. The hub connection fitting 70 comprises a body 72 having aproximal body portion 74, which provides a male connector portion shownto be cylindrical, and a distal body portion 76, which provides a maleconnector portion shown to be cylindrical, separated by anintermediate/middle body portion 78. Hub connection fitting 70 furthercomprises a ventilation passageway 80 which extends through the proximalbody portion 74, intermediate/middle body portion 78 and distal bodyportion 76. Ventilation passageway 80 is to provide fluid communicationbetween ventilation passageway 38 of endotracheal tube 30 and respiratorapparatus 500.

The outer diameter of the proximal body portion 74 of the hub connectionfitting 70 is dimensioned to be inserted into a passageway 502 of arespirator tube 504 of respirator apparatus 500 and interference(frictionally) fit with the inside diameter of the side wall 506thereof. The respirator tube 504 may contact against annularlip/shoulder 82 of intermediate/middle portion 78.

In addition to ventilation passageway 80, hub connection fitting 70includes three secondary passageways 94, 96 and 98 arranged to connectand provide fluid communication with secondary passageways 44, 46 and 48of endotracheal tube 30. As such, secondary passageway 94 defines aportion of the fluid (exhaled gas(es) from the patient) samplingpassageway in fluid communication with fluid sampling port 24 of theendotracheal tube apparatus 20, while secondary passageway 96 defines aportion of the drug delivery passageway in fluid communication with drugdelivery port 26 and secondary passageway 98 defines a portion of thecuff inflation passageway in fluid communication with cuff inflationport 28.

As shown, the secondary passageways 94, 96 and 98 are shown to have anL-shape including a 90 degree bend/angle A. However, while angle A isshown at 90 degrees, the shape and/or angle may be different in otherembodiments. For example, angle A may be in a range of 10 degrees to 170(e.g. 20 degrees to 160 degrees, 30 degrees to 150 degrees, 45 degreesto 135 degrees, 30 degrees to 90 degrees, 90 degrees to 160 degrees, 45degrees to 90 degrees, 90 degrees to 135 degrees) relative to thelongitudinal axis, with an acute angle A being towards the distal bodyportion 76 and an obtuse angle A being towards the proximal body portion74. For example, as shown in phantom, an obtuse angle A′ is shown at 135degrees. The angle A may be made obtuse particularly to make it easierto pass other medical devices down the secondary passageways 94, 96 and98.

Longitudinal (parallel) to the longitudinal axis of the hub connectionfitting 70, within the confines of intermediate/middle portion 78 anddistal body portion 76, secondary passageways 94, 96 and 98 may bedefined by cylindrical side walls 95, 97 and 99, respectively, whicheach form a semi-cylindrical section which is shown to narrow theventilation passageway 80. The distal end of each secondary passageway94, 96 and 98, and more particularly of side walls 95, 97 and 99 may bedefined by a distal male connector portion 104, 106, 108 of the hubconnection fitting 70, which is cylindrical and dimensioned to beinserted into secondary passageways 44, 46 and 48, respectively, ofendotracheal tube 30 and interference (frictionally) fit with the insidediameter of the side walls 54, 56 and 58, respectively. As shown, any orall of the male connector portions 104, 106, and 108 may be formed asone piece with the hub connection fitting body 72. Alternatively, suchmay be formed separately from the hub connection fitting body 72 asseparate pieces. In such regard, the male connector portions 104, 106,and 108 may be made of metal or a plastic different than that of the hubconnection fitting body 72 for increased strength. Such may be welded tothe hub connection fitting body 72 by threaded engagement and/orultrasonic welding, similar to threaded insert.

Thus, the hub connection fitting 70 includes a fluid sampling passagewayconnector (provided by male connector portion 104) which connects to thesecondary passageway 44 of the endotracheal tube 30 for fluid sampling;a drug delivery passageway connector (provided by male connector portion106) which connects to the secondary passageway 46 of the endotrachealtube 30 for drug delivery; and a cuff inflation connector (provided bymale connector portion 108) which connects to the secondary passageway48 of the endotracheal tube 30 for cuff inflation. Further, theendotracheal tube 30 is to preferably contact and butt against annularlip/shoulder 84 of distal body portion 76. In the foregoing manner, allof the passageways may be sealed between endotracheal tube 30 and hubconnection fitting 70 with a fluid (air) tight seal, i.e. a hermeticseal. In certain alternative embodiments, the distal end of eachsecondary passageway 94, 96 and 98 defined by a male connector portion104, 106, 108 may be adhesively bonded with the inside diameter of theside walls 54, 56 and 58, respectively, and the endotracheal tube 30 incontact against annular lip/shoulder 84 of distal body portion 76 mayalso be adhesively bonded with an adhesive.

In certain embodiments, the distal end of each secondary passageway 94,96 and 98 defined by a male connector portion 104, 106, 108 may be alsobe welded with the inside diameter of the side walls 54, 56 and 58,respectively, and proximal end of the endotracheal tube 30 in contactagainst annular lip/shoulder 84 of distal body portion 76 may also bewelded thereto. A thin membrane (e.g. an adhesive bonding tape strip)may also overlie the butt joint around the diameter thereof.Alternatively, as shown in FIG. 2A, an annular ring 90 may overliedistal body portion 76 and be at least one of interference fit, adhesivebonded and welded thereto. Alternatively, annular ring 90 may beprovided as part of the body 72 of hub connection fitting 70, i.e. as asingle piece. As shown, a recess 92 is now formed at the distal end ofdistal body portion 76 into which endotracheal tube 30 may be locatedand at least one of interference fit, adhesive bonded and weldedthereto. It should be understood that any combination of interferencefits, adhesive bonding and welding may be used for any of theconnections alone or in conjunction with another joining method.

The proximal end of each secondary passageway 94, 96, 98 may include acounter-bore 114, 116, 118. Counter-bore 114 is configured to receivethe distal end portion of tubing segment 124, which may be an extrudedtubing segment, in fluid communication with the fluid sampling port 24.Counter-bore 116 is configured to receive the distal end portion oftubing segment 126, which may be an extruded tubing segment, in fluidcommunication with the drug delivery port 26. Counter-bore 118 (on thebackside of the structure, same type of counter-bore as 114 and 116) isconfigured to receive the distal end portion of tubing segment 128,which may be an extruded tubing segment, in fluid communication with thecuff inflation port 28. In order to join the two components together,the distal end portion of tubing segment 124, 126, 128 may beinterference fit with counter-bore 114, 116, 118. Alternatively, or inconjunction with the interference fit, the distal end portion of tubingsegment 124, 126, 128 may be adhesive bonded with counter-bore 114, 116,118 with an adhesive and/or the distal end portion of tubing segment124, 126, 128 may be welded with counter-bore 114, 116, 118.

As shown, the tubing segment 124 in fluid communication with the fluidsampling port 24 includes a passageway (lumen) 134 which forms part ofthe fluid sampling passageway which extends through hub connectionfitting 70 (as secondary passageway 94) and endotracheal tube 30 (assecondary passageway 44). As shown, the proximal end of tubing segment124 is connected to fluid sampling port 24, which comprises a filter 142and fluid sampling port threaded connector 144, which connects fluidsampling port 24 to an analyzing/monitoring apparatus 600. Moreparticularly, fluid sampling port 24 may be a carbon dioxide samplingport, and analyzing/monitoring apparatus 600 may be a carbon dioxideanalyzer/monitor (e.g. a capnograph). Filter 142 may be particularlysuited to separate liquids (e.g. saliva) from the gases (e.g. carbondioxide) exhaled by the patient, such that the gases therein may beanalyzed by a gas analyzer, such as a capnograph, which may detect apresence of carbon dioxide therein. In other embodiments, fluid samplingport 24 may be a sampling port which provides a liquid (e.g. saliva)sample for analysis, with or without a gas sample for analysis. Incertain embodiments, fluid sampling port 24 may include colorimetricpaper 143 to detect a presence of carbon dioxide in the fluid sampleexhaled from the patient. The colorimetric paper 143 (e.g. Kangaroo™ CO₂colorimetric paper from Covidien) may be wrapped around filter 142.

With use of endotracheal tube apparatus 20, gases exhaled by the patientmay enter secondary passageway 44 of endotracheal tube 30 at the distalend opening 42 of endotracheal tube 30, and thereafter flow throughsecondary passageway 94 of hub connection fitting 70 and passageway 134of tubing segment 124, and thereafter through fluid sampling portthreaded connector 144, filter 142 and into analyzing/monitoringapparatus 600. In the foregoing manner, the passageway for the fluidsampling port 24 may be closer positioned to obtain a carbon dioxidesample from the patient nearer the lungs than known sampling ports whichterminate at a proximal end of the endotracheal tube apparatus 20. Asshown, secondary passageway 94 also opens into ventilation passageway 80and is in fluid communication therewith such that a fluid sample may bedrawn from the patient by respirator apparatus 500.

Tubing segment 126 in fluid communication with the drug delivery port 26includes a passageway (lumen) 136 which forms part of the drug deliverypassageway which extends through hub connection fitting 70 (as secondarypassageway 96) and endotracheal tube 30 (as secondary passageway 46). Asshown, the proximal end of tubing segment 126 is connected to a drugdelivery port 26, which comprises a drug delivery port connector 146,which may be particularly suited to a drug delivery device 700, such asa syringe (not shown). In certain embodiments, the drug delivery port26, and more particularly the drug delivery port connector 146 mayinclude a drug aerosolizer as known in the art. As shown, unlikesecondary passageway 94, a proximal end of secondary passageway 96 isnot in fluid communication with ventilation passageway 80.

Tubing segment 128 in fluid communication with the cuff inflation port28 includes a passageway (lumen) 138 which forms part of the cuffinflation passageway which extends through hub connection fitting 70 (assecondary passageway 98) and endotracheal tube 30 (as secondarypassageway 48). As shown, the proximal end of tubing segment 128 isconnected to cuff inflation port 28, which comprises a cuff inflationport connector 148, which connects with a cuff inflation device 800. Asshown, unlike secondary passageway 94, a proximal end of secondarypassageway 98 is not in fluid communication with ventilation passageway80. Also unlike the other passageways, the distal end of the cuffinflation passageway is occluded in a known manner and an aperture isformed in a distal end portion of the outer cylindrical side wall 32 tothe secondary passageway 48, such that the secondary passageway 48 is influid communication with inflation cuff 49 for air to pass through toinflate and deflate the inflation cuff 49.

In the foregoing manner, each of the fluid sampling port 24, drugdelivery port 26 and cuff inflation port 28 connect to the endotrachealtube apparatus 20 via the hub connection fitting 70, which remainsoutside the patient during intubation. As a result, because none of thefluid sampling port 24, drug delivery port 26 and cuff inflation port 28are located between the endotracheal tube 30 and the person's mouthduring use, the tubing segment 124 of fluid sampling port 24, the tubingsegment 126 of drug delivery port 26 and the tubing segment 128 of cuffinflation port 28 are not subject to damage during use, such as beingsevered by the person's teeth in response to a seizure. Also, there isno possibility of the tubing segment 124 of fluid sampling port 24, thetubing segment 126 of drug delivery port 26 or the tubing segment 128 ofcuff inflation port 28 are compressed between the person's mouth and theendotracheal tube 30 during use of endotracheal tube apparatus 20 andnot operating as intended.

In certain embodiments, tubing segment 124 in fluid communication withthe fluid sampling port 24, tubing segment 126 in fluid communicationwith the drug delivery port 26, and/or tubing segment 128 in fluidcommunication with the cuff inflation port 28 may be eliminated suchthat fluid sampling port 24, drug delivery port 26 and cuff inflationport 28 are directly connected to the hub connection body 72 of hubconnection fitting 70.

While the medical device 10 disclosed herein is an endotracheal tubeapparatus 20, it should be understood that the medical device 10 is notnecessarily limited to that of an endotracheal tube apparatus 20, andsuch may provide uses in minimally invasive surgery, as well as morespecific applications such as gastrointestinal and cardiology, and anyother use where multi-lumen tube/tubing in combination with the hubconnection fitting may be utilized. Furthermore, it should be understoodthat the multi-lumen tube/tubing and hub connection fitting are notlimited to one primary (central) passageway and three secondarypassageways, and that any feasible number of passageways may beutilized, such as up to 20 secondary passageways.

Referring to FIG. 6, a medical device 10 comprising a tube 30 and a hubconnection fitting 70 as disclosed herein may be used for medicalinspection, diagnosis and/or treatment where one or more inspection,diagnostic and/or treatment devices are passed through a passageway ofthe medical device 10. Devices which pass through the passageways mayinclude devices for grasping, suturing, stapling, chemically bondingand/or removal of tissue, and/or for removal of foreign bodies, gas,tissue or liquid sampling; and/or for insertion of inspection/diagnosisdevices, treatment devices, a suction device, a camera or other viewingdevice and/or a light for viewing. A camera may be used for continuousviewing during placement of tube apparatus 20. Devices may includecatheters, snares, staplers, and forceps.

As shown in FIG. 7, a lighting apparatus 160 may be incorporated inendotracheal tube apparatus 20. As shown, lighting apparatus 160 maycomprise a lighting device 164, particularly comprising a light source165, such as a light-emitting diode (LED), positioned within one ofsecondary passageways 44, 46 or 48 to emit light from the distal endopening 42 of endotracheal tube 30. The light source 165 may beelectrically connectable to a battery 168 by an electrical conductor166. As shown, battery 168 may be located in one of counter-bores 114,116, 118 of hub connection fitting 70.

When endotracheal tube apparatus 20 is provided by the manufacturer, thebattery 168 may be positioned out of electrical contact with electricalconnector 166 to inhibit the lighting apparatus 160 from powering priorto desired use. In other words, the electrical conductors 166 areinitially arranged in an open circuit. In such regard, a removablenon-conductive liner 170 with a pull tab 172 may be initially positionedbetween the electrical conductor 166 and the battery 168.

Thereafter, when endotracheal tube apparatus 20 is to be used, theremovable non-conductive liner 170 may be removed from hub connectionfitting 70 by simply pulling on pull tab 172, which may establishelectrical contact between battery 168 and electrical conductor 166 topower the light source 165 of lighting device 164. Alternatively, or inaddition to the use of removable non-conductive liner 170, battery 168may also be pushed further into the counter-bore 114, 116 or 118 toestablish electrical contact with electrical conductor 166.

During the insertion of endotracheal tube apparatus 20 into a patient,lighting device 164 may be activated to assist in proper positioning ofthe endotracheal tube apparatus 20 in the trachea as opposed to theesophagus. In doing so, light emitted from lighting device 164 may beobserved through the chest of the patient to further aid in properpositioning.

Light emitted from light source 165 may generally be white (colorless)light, which may be understood as a mixture of all of the wavelengths ofthe visible spectrum, i.e. the visible portion of the electromagneticspectrum. White light may also have a correlated color temperature (CCT)of between about 3000 and 8000 K. White light with a CCT of 4000 or lessmay have a yellowish/reddish color, while white light with a CCT of 8000K may be bluish in color.

In certain applications, the light emitted from light source 165 mayinclude ultraviolet light, which has a frequency of between 10 nm to 380nm. More particularly, the ultraviolet light may be UV-C light having afrequency of between 100 nm to 280 nm. The UV-C light emitted from lightsource 165 may be used for ultraviolet germicidal irradiation (UVGI),which may be understood as a disinfection method which usesshort-wavelength ultraviolet (UV-C) light to kill or inactivatemicroorganisms (e.g. mucus build-up on and/or in the endotracheal tubeor other tubing, as well as the patient).

Referring now to FIGS. 8-13, there is shown another embodiment of amedical device 10 comprising a tube apparatus 20, and more particularlyan endotracheal tube apparatus 20 of a medical (respiratory) system 2(see FIG. 1) according to the present disclosure. As with priorembodiments, while a remainder of the disclosure may refer to the tubeapparatus as being an endotracheal tube apparatus 20, it should beunderstood that the present disclosure is not limited to an endotrachealtube apparatus 20, and the present tube apparatus may have other medicalapplications, as well as non-medical applications, other than that ofendotracheal tube apparatus 20.

As with prior embodiments, the endotracheal tube apparatus 20 comprisesa flexible, elongated, hollow endotracheal tube 30 and a hub connectionfitting 70. Similar to at least one prior embodiment, endotracheal tubeapparatus 20 may include a lighting apparatus 160 (see FIG. 12).

Lighting apparatus 160 may comprise a light-emitting device 162, whichmay include a light-source module 163, coupled with hub connectionfitting body 72. As best shown in FIG. 9, light-source module 163 may beinsertable into and removable from a light-source module receptacle 158formed in the hub connection fitting body 72.

As best shown by FIG. 10, light-source module 163 may comprise one ormore light sources 165, particularly in the form of a lamp such as oneor more light-emitting diodes (LEDs). The LED 165 may be arranged aspart of a light engine, which may comprise an LED driver including aprinted circuit board (PCB) 167 to which the LED 165 is mounted as wellas the electrical wiring/circuitry to control and provide power/signalsto the LED 165.

Light-source module 163 may further comprise a housing 174, providing alight-source housing, which forms a cavity 175 to receive the printedcircuit board (PCB) 167, as well as power source (battery) 168, batteryholder 169 and removable non-conductive liner 170. As shown by FIG. 10,LED 165 and battery holder 169 each provide conductive terminals toelectrically couple LED 165 and battery 168, respectively, to printedcircuit board 167 to establish an electrical circuit there between.

As with the prior embodiment, when endotracheal tube apparatus 20 isprovided by the manufacturer, the battery 168 may be out of electricalcommunication with LED 165 to inhibit the LED 165 from powering prior todesired use. In such regard, a removable non-conductive liner 170 with apull tab 172 may be initially positioned between the electricalconductor 166 and the battery 168 to temporarily disconnect theelectrical circuit.

Thereafter, when endotracheal tube apparatus 20 is to be used, theremovable non-conductive liner 170 may be removed from hub connectionfitting 70 by simply pulling on pull tab 172 with a pulling force, whichmay remove the removable non-conductive liner 170 from hub connectionfitting 70 thus establishing electrical contact between battery 168 andelectrical conductor 166 to provide power to printed circuit board 167and LED 165. As such, it should be understood that lighting apparatus160, and more particularly light-source module 163, makes use of aswitchless design with no “on-off switch.” More particularly, thelighting apparatus 160 is configured for single use and will continue tooperate until power from the battery 168 will no longer provide power tolight the LED 165. However, it should be understood that lightingapparatus 160 may also make use of an on-off switch as such switches areknown in the art.

Once the light-source module 163 is assembled as shown in FIG. 9, it maybe assembled to hub connection fitting body 72 by being inserted intolight-source module receptacle 158 formed in the hub connection fittingbody 72 by sliding light-source module 163 into light-source modulereceptacle 158.

In certain embodiments, after a single use of light-source module 163and the associated power drain of battery 168 upon removal of removablenon-conductive liner 170, it may be possible to detachably removelight-source module 163 from hub connection fitting body 72 by slidingthe light-source module 163 out of light-source module receptacle 158.Thereafter, battery 168 and removable non-conductive liner 170 may bereplaced with a new replacement (charged) battery 168 and a newremovable non-conductive liner 170 for reuse of light-source module 163.

In other embodiments, it may be desirable to inhibit removal oflight-source module 163 from hub connection fitting body 72 to deterreuse of hub connection fitting 70. In such regard, light-source module163 and hub connection fitting body 72 may be adhesively bonded to eachother, particularly by applying an adhesive (e.g. cyanoacrylate, epoxy)to an exterior surface of the housing 174 to be in contact with the hubconnection fitting body 72 prior to inserting the light-source module163 into light-source module receptacle 158. Thereafter, before theadhesive sets (e.g. cures and/or cools), the light-source module 163 maybe slid into light-source module receptacle 158 after which time theadhesive may set. Alternatively, or in addition to the use of a separateadhesive, once the light-source module 163 is slid into light-sourcemodule receptacle 158, the housing 174 and the hub connection fittingbody 72 may be welded together, such as by vibration welding orultrasonic welding in a known manner, for a more permanent assembly.

Referring now to FIGS. 11-13, there are shown various views of thelight-source module 163 coupled with hub connection fitting body 72. Asshown, when properly seated in light-source module receptacle 158, theLED 165 and the portion of the printed circuit board 167 to which LED165 is mounted may enter into ventilation passageway 80 of hubconnection fitting body 72, particularly through a aperture 159 locatedat inner end of the light-source module receptacle 158. As shown, LED165 is arranged to direct light down the longitudinal length of theendotracheal tube 30 along the longitudinal axis, while the thickness ofthe printed circuit board 167 and the battery 168 are arrangedtransverse to the longitudinal axis.

In order to provide increased light emittance at the distal end of tubeapparatus 20, lighting apparatus 160, and more particularly,light-emitting device 162 may further comprise a tubular light guide 178(which may also be referred to as a light tube or pipe) which extendsalong the length of endotracheal tube 30. As shown, the proximal end 179of the tubular light guide 178 may be adjacent (or in contact) andaligned with the LED 165 such that the LED 165 overlies the proximal end179 of the tubular light guide 178 and is optically coupled therewith.As shown, a narrow gap 181, e.g. 0.1 mm to 3 mm, may exist between theLED 165 and the proximal end 179 of the tubular light guide 178.

Tubular light guide 178 may be formed of a bendable, light transmissive(e.g. substantially transparent) cylinder of extruded thermoplasticpolymer (e.g. polycarbonate) or glass. Tubular light guide 178 maycomprise a fiber optic cable having a single elongated optical fiber ora plurality of elongated optical fibers (i.e. a multi-fiber fiber opticcable). Tubular light guide 178 may be a solid cylinder, which maycontain and transmit light by total internal reflection, or a hollowcylinder which may contain and transmit light along a reflective lining.As shown, tubular light guide 178 is a solid, cylindrical elongatedoptical fiber, particularly formed of glass, which may have a diameterin a range of 0.1 mm to 2 mm (including all ranges and increments therebetween) and more particularly in a range of 0.4 mm to 1.1 mm (includingall ranges and increments there between).

Tubular light guide 178 may be located within one of secondarypassageways 44, 46 or 48 to emit light at or adjacent the distal endopening 42 of endotracheal tube 30. As shown, tubular light guide 178 isarranged in secondary passageway 98 of hub connection fitting which isin fluid communication with secondary passageway 48 of endotracheal tube30.

As set forth herein, secondary passageways 98 and 48 define a portion ofthe cuff inflation passageway in fluid communication with cuff inflationport 28 and inflation cuff 49. In the foregoing manner, air pressure toinflate inflation cuff 49 and light to illuminate the distal end of theendotracheal tube 30 may be extended through a single secondarypassageway of hub connection fitting body 72 and endotracheal tube 30 toreduce the overall number of secondary passageways. While the passagewayfor the drug delivery port 26 is not shown, such has been eliminatedfrom the drawing to reduce complexity.

As set forth above, with regards to assembly, the distal end ofsecondary passageway 98 is defined by a male connector portion 108 ofthe hub connection fitting body 72 which is dimensioned to be insertedinto secondary passageway 48 of endotracheal tube 30 and interference(frictionally) fit with the inside diameter of the side wall 58, whilethe proximal end of the endotracheal tube 30 is to contact and buttagainst annular lip/shoulder 84 of distal body portion 76. Further, anannular ring 90 (see FIG. 2A) may overlie distal body portion 76 asdescribed above.

Tubular light guide 178 may be inserted into secondary passageways 98and 48 of the hub connection fitting body 72 and endotracheal tube 30,respectively, before or after the hub connection fitting body 72 andendotracheal tube 30 are assembled. As shown, tubular light guide 178may have an outer diameter which is less than or substantially equal(i.e. within manufacturing tolerance) to the inner diameter of secondarypassageway 98.

In order to seal a proximal end of the secondary passageway 98 againstair leaks (in the case where air pressure to inflate inflation cuff 49and light to light the distal end of the endotracheal tube 30 extendthrough the same secondary passageway of hub connection fitting 70 andendotracheal tube 30), the gap 181 between the LED 165 and the proximalend of secondary passageway 98 and tubular light guide 178 may be filledwith an light transmissive (e.g. substantially transparent) sealingcomposition 101, such as a polymer, adhesive or potting resin. Inaddition, or alternative, the polymer may be located between the insidediameter of secondary passageway 98 and the outside diameter of thetubular light guide 178 adjacent the proximal end thereof(above/proximal to counter-bore 118) to adhesively bond the tubularlight guide 178 to the side wall 99 of secondary passageway 98.

Where tubular light guide 178 has an outer diameter substantially equalto the inner diameter of secondary passageway 98, the secondarypassageway 98 of hub connection fitting 70 may include a semi-circularnotch 100 to facilitate the passage of air through secondary passageway98. Similar to above, the proximal end of the notch 100 of hubconnection fitting 70 may be filled with a sealing composition 101,which may comprise a polymer, adhesive or potting resin, to inhibit airleaks and/or adhesively bond the tubular light guide 178 to the sidewall 99 of secondary passageway 98 of hub connection fitting 70. Notch100 may also be formed within secondary passageway 48 during extrusionof endotracheal tube 30 if so formed by extrusion.

At the distal end of endotracheal tube 30, secondary passageway 48 ofendotracheal tube 30 may be sealed distal to air inlet/outlet opening 50(see FIG. 8) with a plug 182 of light transmissive (e.g. substantiallytransparent) polymer material. The plug 182 may be formed separate fromthe endotracheal tube 30 or formed as one-piece therewith. In the eventof being formed in one piece, a distal end region of the endotrachealtube 30 may be heated and formed into the ventilation passageway 38 toclose the ventilation passageway 38 and provide the plug 182. The distalend 180 of tubular light guide 178 may terminate within secondarypassageway 48 adjacent the plug 182, e.g. less than 3 mm, so the tubularlight guide may slide in secondary passageways 98, 48 in a range of 0.5mm to 6 mm (including all ranges and increments there between) and moreparticularly in a range of 1 mm to 4 mm) including all ranges andincrements there between) as explained below.

If tubular light guide 178 is made bendable, albeit also breakable,material, such as if formed of a glass optical fiber, then it may bedesirable to design the tubular light guide 178 shorter than the overalllength of the secondary passageway 98, 48 in which it resides as setforth above, and merely insert the tubular light guide 178 in secondarypassageways 98, 48 such that the tubular light guide 178 may slidefreely therein. In such case, the tubular light guide 178 may not bebonded to the side wall 99 or 58 of either secondary passageway 98 or48, respectively, but be retained in the secondary passageway 98, 48 bythe LED 165 at the proximal end of the secondary passageway 98 (orsealing composition 101) and the plug 182 at the distal end of thesecondary passageway 48. As a result, the tubular light guide 178 may beless opt to break when endotracheal tube 30 undergoes bending. In theevent it becomes desirable to bond the tubular light guide 178 to theside wall 99 and/or 58 of either secondary passageway 98 or 48,respectively, the tubular light guide 178 should not be bonded at morethan one fixed point, again to inhibit the likelihood of breaking whenendotracheal tube 30 undergoes bending.

Referring to FIGS. 13A-13F, there are shown other embodiments of plug182 of FIG. 8. As shown in FIG. 13A, similar to FIG. 8, the plug body183 of plug 182 is recessed from the distal end 33 of the endotrachealtube 30. In FIG. 13B, the plug 182 is moved distally such that the plugbody 183 is located at the distal end 33 of the endotracheal tube. InFIG. 13C, the plug body 183 may have a blind recess 184 therein toreceive tubular light guide 178. If tubular light guide 178 is to beconnected to the plug body 183, such may provide with an interferencetherewith, or sealing composition 101 being placed therein. In FIG. 13D,rather than having a blind recess 184, plug body 183 may include athrough-hole 185 which extends completely through plug body 183. In suchregards, the distal end 180 of tubular light guide 178 may be located atthe distal end 33 of the endotracheal tube. In FIG. 13E, rather than thedistal end 180 of tubular light guide 178 being recessed or at (parallelwith) the distal end 33 of the endotracheal tube 30, the distal end 180of tubular light guide 178 may extend beyond the distal end 33 of theendotracheal tube 30 (e.g. by 1 mm). In FIG. 13F, in another embodiment,the endotracheal tube 30 is shown to have a plurality of tubular lightguides 178, with the light guide 178 on the left having a plug 182adjacent the distal end 180 thereof, and the light guide 178 on theright not having a plug 182. Both light guides 178 may be used to emitlight, or alternatively be used as temperature sensors (e.g. contactthermometer) as disclosed elsewhere herein to measure core bodytemperature, particularly during therapeutic hypothermia treatment.

Returning to FIG. 13, the present embodiment also includes acounter-bore 114 to receive the distal end portion of tubing segment 124in fluid communication with the fluid sampling port 24. However, incontrast to the previous embodiment, the secondary passageway 94 definedby side wall 95 has been shortened to eliminate male connector portion104, particularly as the corresponding secondary passageway 44 inendotracheal tube 30 has been eliminated. Alternatively, side wall 95may be completely eliminated such that only the counterbore 114 remains.

Similar to the fluid sampling port 24, the secondary passageway 96defined by sidewall 97 may be shortened to eliminate male connectorportion 106. Alternatively, side wall 97 may be completely eliminatedsuch that only the counterbore 116 remains.

Referring briefly to FIGS. 1 and 8, as shown, prior to the fluidsampling port threaded connector 144 (which connects fluid sampling port24 to the analyzing/monitoring apparatus 600), tubing segment 124 mayinclude a connectable and disconnectable mating first and secondconnectors 125 a, 125 b. Connectors 125 a, 125 b may more particularlyinclude a one-way valve, which only allow exhaled gas(es) from thepatient within tubing segment 124 to travel towards analyzing/monitoringapparatus 600. Further, first connector 125 a may close the valve andpassageway 134 in the event of disconnection.

During use of fluid sampling port 24, in the event passageway 134 priorto first connector 125 becomes clogged with mucus, saliva or othersecretions, the first and second connectors 125 a, 125 b may bedisconnected from one another without a change in pressure (positive ornegative) within ventilation passageway 38. Thereafter, a syringe 650may be connected to first fastener 125 a to reopen the one-way valve andinject air into passageway 134 to remove the secretions therein byforcing them back to the ventilation passageway 38. Thereafter, thesyringe 650 may be disconnected from first fastener 125 a, and firstfastener 125 a may be reconnected with second fastener 125 b.

Referring now to FIG. 14, there is shown another embodiment of medicaldevice 10 comprising a tube apparatus 20, and more particularly anendotracheal tube apparatus 20 of a medical (respiratory) system 2according to the present disclosure. In contrast to the priorembodiment, when properly seated in light-source module receptacle 158,the LED 165 and the portion of the printed circuit board 167 to whichLED 165 is mounted do not enter into ventilation passageway 80 of hubconnection fitting body 72. As shown, LED 165 is arranged to directlight transverse to the longitudinal length of ventilation passageway 80and transverse to the longitudinal axis, while the thickness of theprinted circuit board 167 and the battery 168 are arranged parallel tothe longitudinal axis.

In order for light from LED 165 to be directed down the longitudinallength of ventilation passageway 80 along the longitudinal axis, housing174 may include a 90 degree elbow 173 having a light reflective surface176 to redirect light from LED 165 approximately 90 degrees such thelight from LED 165 is directed down the longitudinal length of secondarypassageways 48, 98 along the longitudinal axis.

In addition to redirecting light from LED 165, elbow 173 also may sealagainst cylindrical side wall 99 defining secondary passageway 98. Insuch manner, the gap 181 between the LED 165 and the proximal end ofsecondary passageway 98 and tubular light guide 178 of the priorembodiment is also eliminated, along with the potential need to seal theproximal end of the secondary passageway 98 against air leaks.

As may be understood from the foregoing embodiments, the tube apparatus20, such as an endotracheal tube apparatus, may incorporate a lightingapparatus 160 to provide visual aid during endotracheal intubation tobetter ensure proper placement of the endotracheal tube in the trachea.

Referring now to FIG. 15, there is shown another embodiment of medicaldevice 10 comprising a tube apparatus 20, and more particularly anendotracheal tube apparatus 20 of a medical (respiratory) system 2according to the present disclosure. As shown, the light-emitting device162 has been completely eliminated. Furthermore, rather than forming abutt joint between distal body portion 76 and endotracheal tube 30, alap joint is shown such that the inner diameter of the proximal endportion of endotracheal tube 30 overlaps and forms an interference fitwith the outer diameter of the distal body portion 76 of hub connectionfitting 70 and butts up against annual lip/shoulder 86.

With the tube apparatus 20 of FIG. 15, the outer diameter of distal bodyportion 76 may be changed, particularly through modifying the injectionmold tooling. As such, hub connection fittings 70 may be made with theouter diameter of distal body portion 76 having differing diameters. Insuch fashion, the various outer diameters of distal body portion 76 maybe used to form the overlap joint with an interference fit toendotracheal tubes 30 or other tubes 30 with varying inner diameters.

Referring now to FIGS. 16-17, there is shown another embodiment of amedical device 10 comprising a tube apparatus 20, and more particularlyan endotracheal tube apparatus 20 of a medical (respiratory) system 2(see FIG. 1) according to the present disclosure. As with priorembodiments, while a remainder of the disclosure may refer to the tubeapparatus as being an endotracheal tube apparatus 20, it should beunderstood that the present disclosure is not limited to an endotrachealtube apparatus 20, and the present tube apparatus may have other medicalapplications, as well as non-medical applications, other than that ofendotracheal tube apparatus 20.

As with prior embodiments, the endotracheal tube apparatus 20 comprisesa flexible, elongated, hollow endotracheal tube 30 and a hub connectionfitting 70. Similar to at least one prior embodiment, endotracheal tubeapparatus 20 may include a lighting apparatus 160 (see FIG. 12).

Endotracheal tube apparatus 20 may further comprise a sensor apparatus200, such as a gas sensor apparatus arranged to detect one or morerespiration gases exhaled by a patient. More particularly, the sensorapparatus 200 may be arranged to detect the existence or non-existenceof at least one particular gas within the composition of respirationgases exhaled by a patient. Even more particularly, sensor apparatus 200may be arranged to detect a level of at least one particular gas withinthe composition of respiration gas exhaled by a patient (e.g. detectcarbon dioxide gas). In such a manner, sensor apparatus 200 then maydetermine whether the level of the particular gas being exhaled by thepatient is below or above values which are generally recognized as beingnormal for purposes of determining further treatment.

As shown, sensor apparatus 200 may comprise at least one sensor 202,which may be provided by one or more sensor modules 204 coupled withinhub connection fitting body 72. Sensor module 204 may be insertable andremovable into a sensor module receptacle 206 formed in the hubconnection fitting body 72.

Sensor 202 may be configured to detect one or more respiration gasesexhaled by the patient, particularly carbon dioxide. As explained ingreater detail below, sensor 202 may be a carbon dioxide sensor, such asparticularly used for non-diverging capnography.

Capnography may be understood as the monitoring of the concentration orpartial pressure of carbon dioxide gas in a patient's respiratory gases.Carbon dioxide monitoring may be performed using either diverting ornon-diverting sampling, which may alternatively be referred to assidestream or mainstream sampling, respectively. With use of divertingor sidestream capnography, a portion of a patient's respirated gases aretransported from the sampling site through sampling tubing to a carbondioxide sensor in a capnograph (which may also be referred to as acapnometer) as set forth with the foregoing embodiments. Alternatively,with use of non-diverting or mainstream capnography, the patient'srespirated gases are analyzed at the sampling site by the carbon dioxidesensor, rather than being transported from the sampling site throughsampling tubing to carbon dioxide sensor in the capnograph. Statedanother way, the difference between mainstream (non-diverting)capnography and sidestream (diverting) capnography may be understood asmeasuring carbon dioxide at the sampling site (in the endotrachealapparatus) versus measuring carbon dioxide at a monitor location remotefrom the sampling site. Because non-diverting capnography measurescarbon dioxide at or closer to the sampling site, the data is closer toreal time.

As set forth above, sensor 202 may be a carbon dioxide sensor. Moreparticularly, sensor 202 may be a spectroscopic sensor and moreparticularly an infrared gas sensor, such as a nondispersive infraredsensor, given that carbon dioxide absorbs infrared radiation. In generaloperation, a beam of infrared light passed across the gas sample fallson the infrared sensor. The presence of carbon dioxide in the gas leadsto a reduction in the amount of light falling on the sensor, whichchanges the voltage output in a circuit. Thus, it may be understood thatwhen no carbon dioxide is in the expired gases of a patient, the voltagelevel would be at its highest, and when a maximum level of carbondioxide is in the expired gases of a patient, the voltage level would beat its lowest. The voltage change over time may then be converted usingan algorithm to an output graph of expiratory carbon dioxide which maybe measured in millimeters of mercury (“mmHg”) plotted against time, or,less commonly, but more usefully, expired volumetric concentration ofcarbon dioxide. Thus, the light intensity is detected and may beconverted into a voltage signal which is correlated to a gasconcentration value by the algorithm.

As such, sensor 202 may further comprise an infrared emitter 210 and aninfrared detector 220. An interference filter 218 may be located infront of the infrared detector 220 to prevent wavelengths other thanthat specific to the measured gas from passing through to the detector.Alternatively, or in addition to, the window of the infrared detector220 maybe coated with sapphire to avoid condensation thereon which couldadversely affect readings. Infrared emitter 210 and infrared detector220 may be aligned on opposing sides of the ventilation passageway 80such that infrared light emitted from infrared emitter 210 is detectedby infrared detector 220.

Infrared emitter 210 may comprise one or more infrared light sources 212particularly in the form of a lamp such as one or more infraredlight-emitting diodes (LEDs). Infrared LED 212 may be part oflight-source module 163 if such is included with the particularembodiment of medical device 10, in which case light-source module maydouble as a combined sensor module.

Similar to LED 165, LED 212 may be arranged as part of a light engine,which may comprise an LED driver including a printed circuit board (PCB)167 to which the LED 212 is mounted as well as the electricalwiring/circuitry to control and provide power/signals to the LED 212.Also similar to LED 165, LED 212 may receive power from power source(battery) 168 held in battery holder 169 and be activated with theremoval of removable non-conductive liner 170. Power source 168 may alsobe used to heat the infrared emitter 210 and an infrared detector 220,such as by use of a resistor located adjacent thereto to prevent orreduce condensation.

In alternative embodiments, if light-source module 163 is not includedwith the medical device 10, then light-source module 163 mayparticularly function solely as a sensor module with the operation ofinfrared emitter 210.

Similar to module 163, sensor module 204 may include a housing 174,which forms a cavity 175 to receive the printed circuit board (PCB) 167,as well as power source (battery) 168, battery holder 169 and removablenon-conductive liner 170. As shown by FIG. 17, battery holder 169 mayprovide conductive terminals to electrically couple battery 168 toprinted circuit board 167 and infrared detector 220 to establish anelectrical circuit there between. With the foregoing arrangement,infrared detector 220 may be powered for use by battery 168.

Infrared detector 220 is arranged to detect infrared light from infraredlight source 212 of infrared emitter 210. As set forth above, presenceof carbon dioxide in the gas leads to a reduction in the amount of lightfalling on the infrared detector 220, which changes the output of thedetector 220, such as voltage.

The infrared light source 212 may be set to emit a specific infraredlight wavelength spectrum depending on the target gas. It may beunderstood that each gas expelled will absorb infrared wavelengthsdifferently. For example, carbon dioxide absorbs infrared waves withwavelengths of about 4.25 micrometers, while oxygen does not absorb atall.

In addition to the foregoing components, sensor module 204 may furthercomprise a micro-processor 230, a non-transitory computer-readablestorage medium 240 (e.g. memory) and a communication element 250, whichmay all be incorporated on printed circuit board (PCB) 167.

Infrared detector 220 may be electrically and operationally connected,particularly via printed circuit board (PCB) 167, to micro-processor 230and non-transitory computer-readable storage medium 240 to recordoperational data, which may be stored on medical device 10, and moreparticularly hub connection fitting 70.

The operation data may also be communicated to at least one remoteelectronic device 900, which may be part of a computer communicationnetwork, at near real time with communication element 250. In the eventthe operational data is communicated to the computer(s) of thecommunication network, such may also be stored in a non-transitorycomputer-readable storage medium of the computer(s) of the communicationnetwork, or communicated and stored on another computer(s) of anothercommunication network. At least one remote electronic device maycomprise a computer such as a desktop computer, a portable computer suchas a laptop computer, a notebook computer, a netbook (with or without akeyboard such as an iPad), a personal digital assistant (PDA), or awearable computer, a cellphone computer or other handheld computer (e.g.smartphone).

The communication element 250 may transmit electronic communication to,and receive electronic communication from, the computer(s) of thecommunication network using wireless communication standards andprotocols (e.g. WiFi, Bluetooth, cellular). As such, it should beunderstood that the communication element 250 of medical device 10 mayparticularly be either a one-way communication element (e.g.transmitter) or a two-way communication element (e.g. transmitter and/orreceiver, such as a transceiver) for allowing the medical device 10, andmore particularly hub connection fitting 70, to communicate with thecomputer(s) of computer network. Thus, medical device 10, and moreparticularly hub connection fitting 70 may contain all the computer(software) application programs and electronic circuitry to enablecommunication therebetween, such as signals which may include data (e.g.raw, interpreted, binary). In addition to one or more computerprocessors, such circuitry may include digital and analog integratedcircuits, resistors, capacitors, transistors and other semiconductorsand other electronic components known to those skilled in the art.

In the foregoing manner, medical device 10, and more particularly hubconnection fitting 70 may transmit data (e.g. voltage signalsrepresentative of carbon dioxide presence) via the transmitter to thecomputer(s) of the communication network. The computer(s) of thecomputer network, and more particularly (micro) processor(s) of thecomputer(s) may then convert the data/signals to an output (e.g. graphand/or numerical display) representative of expiratory carbon dioxideusing hardware and/or software including an algorithm, which may beshown on a computer output display. A display may be understood as acomputer output surface and projecting mechanism that shows text andoften graphic images to the computer user, using a cathode ray tube(CRT), liquid crystal display (LCD), light-emitting diode (LED), gasplasma (GS), or other image projection technology. The display may be atouch activated screen.

Alternatively, the processor 250 of the hub connection fitting 70, andmore particularly the sensor module 204, may convert the data/signals toan output (e.g. graph and/or numerical display) representative ofexpiratory carbon dioxide using hardware and/or software including analgorithm. The output graph and/or numerical display of expiratorycarbon dioxide may then be transmitted to the computer(s) of thecommunication network for display on a computer display of thecomputer(s) of the communication network, or displayed on the medicaldevice.

In other embodiments, medical device, and more particularly sensormodule 204, may include its own output display 260 which may be anumeric display of expiratory carbon dioxide. The output display 260 maybe an LED display, which may be similar in size to that of a digitalwatch.

As an alternative to a graphical or numeric display, output display 260of medical device, and more particularly sensor module 204, may includea plurality of output lights which correspond to different levels ofmeasured carbon dioxide, such as a red LED, a yellow LED and a greenLED. For example, a lighted red LED would be indicative of no measuredcarbon dioxide, a lighted yellow LED would be indicative of a low levelof measured carbon dioxide and a lighted green LED would be indicativeof a suitable level of measured carbon dioxide. Alternatively, a singlelighted LED would be indicative of no measured carbon dioxide, twolighted LEDs would be indicative of a low level of measured carbondioxide and three lighted LEDs would be indicative of a suitable levelof measured carbon dioxide. The LEDs may be the same or differentcolors. Similarly, the light output from LED 165 may also change colorswhen the sensor apparatus 200 is in use. For example, when sensorapparatus 200 is not in use, LED 165 may emit white (colorless) light.However, when sensor apparatus 200 is in use, light from LED 165 may gofrom white light to various colors of the electromagmetic spectrum. Forexample, red light (wavelength between 610 nm and 750 nm) may beindicative of no measured carbon dioxide, yellow light (wavelengthbetween 570 nm and 590 nm) may be indicative of a low level of measuredcarbon dioxide and green light (wavelength between 495 nm and 570 nm)may be indicative of a suitable level of measured carbon dioxide.

It also may be beneficial for LED 165 to only emit red light, such asfor medical personnel treating soldiers in the field. As opposed towhite light, the red light emitted by LED 165 may be less detectable byan enemy combatant.

In the foregoing manner, medical device 10, and more particularly hubconnection fitting 70 may also receive communication from one or morecomputers of a computer network. Such may be used to calibrate thesensor 202 prior to use with a known concentration of the target gas.

In other embodiments, sensor 202 when comprising a carbon dioxidesensor, may use technologies other than capnography to detect andmeasure carbon dioxide. For example sensor 202 may be a chemical carbondioxide sensor, or an electro-chemical carbon dioxide sensor as known inthe art. Sensor 202 may also be a raman spectroscopy sensor, such as asurface-enhanced raman spectroscopy sensor, a photoacoustic sensor (e.g.for photoacoustic spectroscopy) or a mass spectrometry sensor.

In other embodiments, as shown in FIG. 18, a single sensor module 204may include both the infrared emitted 210 and the infrared detector 220arranged in a housing 174, which is semi-circular. In FIG. 19, thehousing may be annular and define a portion of ventilation passageway80.

In other embodiments, sensor apparatus 200, and more particular sensor202, may comprise a temperature sensor, such as athermistor/thermocouple, particularly to measure temperature of inhaledand exhaled respiratory gas(es) of the patient. In other embodiments, atemperature sensor and method of use as disclosed in U.S. Pat. No.8,323,207 to Popov et al., hereby incorporated by reference, may be usedto measure temperature of inhaled and exhaled respiratory gas(es) of thepatient.

In still other embodiments, the tubular light guide 178 may be part ofthe sensor 202, and more particularly a temperature sensor, in whichcase the temperature sensor may comprise a fiber optical thermometer,which may make use of a gallium arsenide (GaAs) semiconductor crystalthat is mounted on the end of the tubular light guide 178. In suchinstance, second light guide 178 may be used for the fiber opticalthermometer in addition to a first light guide 178 to emit light (seeFIG. 13B).

In still other embodiments, alternatively or in addition to, sensorapparatus 200 may include sensors 202 to detect and/or quantify othergas(es) within the composition of respiration gas exhaled by a patientother than carbon dioxide, such as oxygen, nitrogen, and carbon monoxide(to detect carbon monoxide poisoning), using known sensor technologieswhich may be incorporated into tube apparatus 20, such as hub connectionfitting 70.

As may be understood from the foregoing embodiments, the tube apparatus20, such as an endotracheal apparatus, may also incorporate a sensorapparatus 200 to detect one or more physiological parameters applicableto the health state of a host to reduce or eliminate reliance onadditional equipment to perform such detection.

As also set forth above, tube apparatus 20, and more particularly anendotracheal tube apparatus, may reduce stack-up of multiple componentsand associated air leaks occurring there between by combining multiplefeatures into a hub connection fitting 70 of the endotracheal tubeapparatus 20.

For example, a conventional medical device stack-up to perform pulmonaryventilation on a patient in cardiac arrest may first involves intubationwith a endotracheal tube, which includes a standard connection piece atthe working end. Once intubated by medical personnel, a separatediverging capnography adaptor may then be connected to the standardconnection piece of the endotracheal tube as dictated by standard ofcare. Attachment of the diverging capnography adaptor is required toconfirm proper placement of the endotracheal tube, continuously monitorfor carbon dioxide output and identify a return to spontaneouscirculation. Thereafter, an impedance threshold device (ITD) may beconnected to the top of the diverging capnography adaptor and a bagvalve mask (BVM) is connected to the top of the impedance thresholddevice (ITD). Alternatively, the order of capnography adaptor andimpedance threshold (ITD) may be reversed in the foregoing stack-up.

A medical device 10 comprising a tube 30 and a hub connection fitting 70as disclosed herein may comprise other airway management devices, suchas a supraglottic airway laryngopharyngeal tube (SALT) apparatus, whichcomprises an supraglottic airway laryngopharyngeal tube and a hubconnection fitting.

A medical device 10 comprising a tube 30 and a hub connection fitting 70as disclosed herein may be used in pulmonary applications involvinginspection, diagnosis and/or treatment where one or more devices arepassed through each passageway to perform procedures in the lungs, suchas lung resection or biopsy sample (tissue) extraction.

A medical device 10 comprising a tube 30 and a hub connection fitting 70as disclosed herein may be used in gastrointestinal applicationsinvolving inspection, diagnosis and/or treatment where one or moredevices are passed through each passageway to perform procedures in thegastrointestinal tract. Such procedures may involve the esophagus,stomach, intestines such as the duodenum, and the colon. Specificprocedures may include gastric bypass or other stomach reduction.

A medical device 10 comprising a tube 30 and a hub connection fitting 70as disclosed herein may be used in cardiology for the insertion ofpacing leads or other diagnostic electrical leads.

For minimally invasive surgery, multiple surgical related devices can beinserted through the tube 30 and a hub connection fitting 70 to theprocedure site, which each device using a separate lumen of the tube 30and a hub connection fitting 70 to improve control, safety and/orefficacy of the surgical devices.

In the foregoing applications, it should be understood that the tube 30and a hub connection fitting 70 may both have appropriately sizedpassageways for such applications, which may be larger or smaller thanthe passageways required for use as an endotracheal tube apparatus. Assuch, the tube 30 and a hub connection fitting 70 may be provided inkits with multiple quantities, sizes and angle of the passagewaysthrough the hub connection fitting 70. The number of passageways is onlylimited by the outside dimensions of the tube and required internaldimensions of the passageways.

Referring now to FIGS. 20A-25B, there is shown another embodiment of amedical device 10 comprising a tube apparatus 20, and more particularlyan endotracheal tube apparatus 20 of a medical (respiratory) system 2(see FIG. 1) according to the present disclosure. As with priorembodiments, while a remainder of the disclosure may refer to the tubeapparatus as being an endotracheal tube apparatus 20, it should beunderstood that the present disclosure is not limited to an endotrachealtube apparatus 20, and the present tube apparatus may have other medicalapplications, as well as non-medical applications, other than that ofendotracheal tube apparatus 20.

As shown in FIGS. 20A-20D, as with prior embodiments, the endotrachealtube apparatus 20 comprises a flexible, elongated, hollow endotrachealtube 30 and a hub connection fitting 70. For simplicity, only a proximalregion of the endotracheal tube 30 is shown, however, it may beunderstood that the distal region of the endotracheal tube 30 may be thesame as the distal region of the endotracheal tube 30 shown in FIG. 8.Additional views of the hub connection fitting 70 and endotracheal tubeprior to assembly are shown in FIGS. 21A-21I and FIGS. 22A-22B,respectively.

Referring now to FIG. 20D, similar to at least one prior embodiment,endotracheal tube apparatus 20 may include a lighting apparatus 160.Lighting apparatus 160 may comprise a light-emitting device 162, whichmay include a light-source module 163 coupled with hub connectionfitting body 72. Similar to FIG. 9, light-source module 163 may beinsertable into and removable from a light-source module receptacle 158formed in the hub connection fitting body 72.

With particular reference to FIG. 20D, light-source module 163 maycomprise one or more light sources 165, particularly in the form of alamp such as one or more light-emitting diodes (LEDs). The LED 165 maybe arranged as part of a light engine, which may comprise an LED driverincluding a printed circuit board (PCB) 167 to which the LED 165 ismounted as well as the electrical wiring/circuitry to control andprovide power/signals to the LED 165.

Similar to FIG. 10, and as shown in FIG. 20D, light-source module 163may further comprise a housing 174, which forms a cavity 175 to receivethe printed circuit board (PCB) 167, as well as power source (battery)168, battery holder 169 and removable non-conductive liner 170 whichextends through aperture 171. Similar to FIG. 10, LED 165 and batteryholder 169 each provide conductive terminals to electrically couple LED165 and battery 168, respectively, to printed circuit board 167 toestablish an electrical circuit there between. Additional views of thelight source module 163 are shown in FIGS. 23A-23D and FIGS. 24A-24B. Asshown in FIG. 24B, the inner surfaces of the housing 174 may be madereflective, such as with a reflective coating 161, to inhibit light fromLED 165 from projecting upwards from the hub connection fitting 70.

As shown in FIG. 20D, similar to at least one prior embodiment, whenendotracheal tube apparatus 20 is provided by the manufacturer, thebattery 168 may be out of electrical communication with LED 165 toinhibit the LED 165 from powering prior to desired use. In such regard,a removable non-conductive liner 170 with a pull tab 172 may beinitially positioned between the electrical conductor 166 and thebattery 168 to temporarily disconnect the electrical circuit.

Thereafter, when endotracheal tube apparatus 20 is to be used, theremovable non-conductive liner 170 may be removed from hub connectionfitting 70 by simply pulling on pull tab 172 with a pulling force, whichmay remove the removable non-conductive liner 170 from hub connectionfitting 70 the establish electrical contact between battery 168 andelectrical conductor 166 to provide power to printed circuit board 167and LED 165. As such, it should be understood that lighting apparatus160, and more particularly light-source module 163, makes use of aswitchless design with no “on-off switch.” More particularly, thelighting apparatus 160 is configured for single use and will continue tooperate until power from the battery 168 will no longer provide power tolight the LED 165. However, it should be understood that lightingapparatus 160 may also make use of an on-off switch as such switches areknown in the art.

Once the light-source module 163 is assembled similar to FIG. 9, it maybe assembled to hub connection fitting body 72 by being inserted intolight-source module receptacle 158 formed in the hub connection fittingbody 72 by sliding light-source module 163 into light-source modulereceptacle 158.

In certain embodiments, after a single use of light-source module 163and the associated power drain of battery 168 upon removal of removablenon-conductive liner 170, it may be possible to detachably removelight-source module 163 from hub connection fitting body 72 by slidingthe light-source module 163 out of light-source module receptacle 158.Thereafter, battery 168 and removable non-conductive liner 170 may bereplaced with a new replacement (charged) battery 168 and a newremovable non-conductive liner 170 for reuse of light-source module 163.

In other embodiments, it may be desirable to inhibit removal oflight-source module 163 from hub connection fitting body 72 to deterreuse of hub connection fitting 70. In such regard, light-source module163 and hub connection fitting body 72 may be adhesively bonded to eachother, particularly by applying an adhesive (e.g. cyanoacrylate, epoxy)to an exterior surface of the housing 174 to be in contact with the hubconnection fitting body 72 prior to inserting the light-source module163 into light-source module receptacle 158. Thereafter, before theadhesive sets (e.g. cures and/or cools), the light-source module 163 maybe slid into light-source module receptacle 158 after which time theadhesive may set. Alternatively, or in addition to the use of a separateadhesive, once the light-source module 163 is slid into light-sourcemodule receptacle 158, the housing 174 and the hub connection fittingbody 72 may be welded together, such as by vibration welding orultrasonic welding in a known manner, for a more permanent assembly.

Similar to the embodiment of FIGS. 8-13, LED 165 is arranged to directlight down the longitudinal length of the endotracheal tube 30 along thelongitudinal axis, while the thickness of the printed circuit board 167and the battery 168 are arranged transverse to the longitudinal axis.Also similar to the embodiment of FIGS. 8-13, in order to provideincreased light emittance at the distal end of tube apparatus 20,lighting apparatus 160, and more particularly, light-emitting device 162may further comprise a tubular light guide 178 which extends along thelength of endotracheal tube 30.

As shown, light from LED 165 is transmitted through a wall 177 of thelight-source module receptacle 158 of hub connection fitting body 72which is beneath the LED 165, with the proximal end 179 of the tubularlight guide 178 adjacent and aligned with the LED 165 such that the LED165 overlies the proximal end 179 of the tubular light guide 178.

In such embodiment, the hub connection fitting body 72, and moreparticularly wall 177, is light transmissive to visible light (e.g.substantially transparent). In such regards, the hub connection fitting72 may be made of polycarbonate or polymethylmethacrylate (acrylic).

As a result of light from LED 165 passing through wall 177 beforeentering tubular light guide 178, in contrast to the embodiment of FIGS.8-13, the hub connection fitting body 72 does not need to include anaperture 159 located at inner end of the light-source module receptacle158, and the LED 165 and the portion of the printed circuit board 167 towhich LED 165 is mounted do not enter into ventilation passageway 80 ofhub connection fitting body 72.

Tubular light guide 178 may be formed of a bendable, light transmissive(e.g. substantially transparent) cylinder of extruded thermoplasticpolymer (e.g. polycarbonate) or glass. Tubular light guide 178 maycomprise a fiber optic cable having a single elongated optical fiber ora plurality of elongated optical fibers (i.e. a multi-fiber fiber opticcable). Tubular light guide 178 may be a solid cylinder, which maycontain and transmit light by total internal reflection, or a hollowcylinder which may contain and transmit light along a reflective lining.As shown, tubular light guide 178 is a solid, cylindrical elongatedoptical fiber, particularly formed of glass, which may have a diameterin a range of 0.1 mm to 2 mm (including all ranges and increments therebetween) and more particularly in a range of 0.4 mm to 1.1 mm (includingall ranges and increments there between).

Tubular light guide 178 may be located within one of secondarypassageways 44, 46 or 48 to emit light at or adjacent the distal endopening 42 of endotracheal tube 30. As shown, tubular light guide 178 isarranged in secondary passageway 98 of hub connection fitting which isin fluid communication with secondary passageway 48 of endotracheal tube30.

As set forth herein, secondary passageways 98 and 48 define a portion ofthe cuff inflation passageway in fluid communication with cuff inflationport 28 and inflation cuff 49. In the foregoing manner, air pressure toinflate inflation cuff 49 and light to illuminate the distal end of theendotracheal tube 30 may be extended through a single secondarypassageway of hub connection fitting body 72 and endotracheal tube 30 toreduce the overall number of secondary passageways. While the passagewayfor the drug delivery port 26 is not shown, such has been eliminatedfrom the drawing to reduce complexity.

Similar to the embodiment of FIGS. 8-13, with regards to assembly, thedistal end of secondary passageway 98 is defined by a male connectorportion 108 of the hub connection fitting body 72 which is dimensionedto be inserted into secondary passageway 48 of endotracheal tube 30 andinterference (frictionally) fit with the inside diameter of the sidewall 58, while the proximal end of the endotracheal tube 30 is tocontact and butt against annular lip 84 of distal body portion 76.

Further, annular ring 90, which was initially separate from the hubconnection fitting body 72 is now provided as one piece with the hubconnection fitting body 72 and form a recess/cavity 92 into which aproximal end (cylindrical) region 39 of the endotracheal tube 30 may beinserted and overlap against, particularly with the outer surface 34 ofthe proximal end (cylindrical) region 39 of the endotracheal tube 30 incontact with the inner (cylindrical) surface 91 of the recess 92. Itshould be understood that any combination of interference fits, adhesivebonding and welding may be used to mechanically (positive mechanicaland/or friction) and/or adhesively join the proximal end (cylindrical)region 39 of the endotracheal tube 30 within recess 92, particularlywith the outer surface 34 of the proximal end (cylindrical) region 39 ofthe endotracheal tube 30 in contact with the inner (cylindrical) surface91 of the recess 92. For example, the outer surface 34 of the proximalend (cylindrical) region 39 of the endotracheal tube 30 may be at leastone of interference fit, adhesive bonded and welded with the inner(cylindrical) surface 91 of the recess 92. It should be understood thatany combination of interference fits, adhesive bonding and welding maybe used for any of the connections alone or in conjunction with anotherjoining method.

Tubular light guide 178 may be inserted into secondary passageway 98 ofhub connection fitting body 72 and secondary passageway 48 ofendotracheal tube 30 before or after the hub connection fitting body 72and endotracheal tube 30 are assembled. As shown, tubular light guide178 may have an outer diameter which is less than or substantially equal(i.e. within manufacturing tolerance) to the inner diameter of secondarypassageway 98.

In a particular method of assembly, the tubular light guide 178 mayfirst be inserted into secondary passageway 48 of endotracheal tube 30until the distal end 180 of the tubular light guide 178 makes contactwith plug 182 already inserted therein. A remaining proximal end portionof the tubular light guide 178 not contained within the secondarypassageway 48 of endotracheal tube 30 may then be inserted into thesecondary passageway 98 of hub connection fitting body 72 until maleconnector portion 108 is inserted in secondary passageway 48 ofendotracheal tube 30. Tubular light guide 178 may then be retained inthe secondary passageway 98, 48 between the wall 177 of hub connectionfitting body 72 and plug 182 of endotracheal tube 30.

Unlike the embodiment of FIGS. 8-13, wall 177 of the hub connectionfitting closes the proximal end of secondary passageway 98. As a result,no sealing composition 101 is required to seal a proximal end of thesecondary passageway 98 against air leaks (in the case where airpressure to inflate inflation cuff 49 and light to light the distal endof the endotracheal tube 30 extend through the same secondary passageway98, 48 of hub connection fitting body 72 and endotracheal tube 30), thegap 181 between the LED 165 and the proximal end of secondary passageway98 and tubular light guide 178.

In the event is it desirable to adhesively bond the tubular light guide178 to the side wall 99 of secondary passageway 98, particularly to fixone end of the tubular light guide 178 to hub connection fitting body72, the sealing composition 101 may be introduced through injection port186. As with the embodiment of FIGS. 8-13, the polymer may be locatedbetween the inside diameter of secondary passageway 98 and the outsidediameter of the tubular light guide 178 adjacent the distal end thereof(above/proximal to counter-bore 118) to adhesively bond the tubularlight guide 178 to the side wall 99 of secondary passageway 98. Inaddition to or as an alternative to sealing composition 101, acylindrical (annular) bushing 187 may be used to retain the tubularlight guide 178 to hub connection fitting body 72.

While not shown, as with the embodiment of FIGS. 8-13, secondarypassageway 48 of endotracheal tube 30 may be sealed distal to airinlet/outlet opening 50 (see FIG. 8) with a plug 182 of lighttransmissive (e.g. substantially transparent) polymer material.

As with the embodiment of FIGS. 8-13, it may be desirable for thetubular light guide 178 to be shorter than the overall length of thesecondary passageway 98, 48 such that the tubular light guide 178 mayslide freely therein. Similarly, the tubular light guide may slide insecondary passageways 98, 48 in a range of 0.5 mm to 6 mm (including allranges and increments there between) and more particularly in a range of1 mm to 4 mm) including all ranges and increments there between).

In such case, the tubular light guide 178 may not be bonded to the sidewall 99 or 58 of either secondary passageway 98 or 48, respectively, butbe retained in the secondary passageway 98, 48 between wall 177 of hubconnection fitting body 72 and the plug 182 at the distal end of thesecondary passageway 48. As a result, the tubular light guide 178 may beless opt to break when endotracheal tube 30 undergoes bending. In theevent it becomes desirable to bond the tubular light guide 178 to theside wall 99 and/or 58 of either secondary passageway 98 or 48,respectively, the tubular light guide 178 should not be bonded at morethan one fixed point, again to inhibit the likelihood of breaking whenendotracheal tube 30 undergoes bending.

In order to reduce the diameter of secondary passageway 48 potentiallyto the smallest diameter to accommodate tubular light guide 178, aproximal end region 43 of a length of the secondary passageway 48 isflared such that it has a greater inner diameter than the remainingdistal region of the length of secondary passageway 48. In such amanner, the larger diameter of the proximal end region 43 of thesecondary passageway 48 as compared to the more distal region of thelength of secondary passageway 48 may better accommodate the insertionof male connector portion 108 therein.

Similar to the embodiment of FIGS. 8-13, counter-bore 118 is configuredto receive the distal end portion of tubing segment 128 in fluidcommunication with the cuff inflation port 28, which comprises a cuffinflation port connector 148, which connects with a cuff inflationdevice 800.

Similar to the embodiment of FIGS. 8-13, the present embodiment alsoincludes a counter-bore 114 to receive the distal end portion of tubingsegment 124 in fluid communication with the fluid sampling port 24,which may comprise a filter 142 and fluid sampling port threadedconnector 144, which connects fluid sampling port to ananalyzing/monitoring apparatus 600. Also similar to the embodiment ofFIGS. 8-13, the secondary passageway 94 defined by side wall 95 has beenshortened to eliminate male connector portion 104, particularly as thecorresponding secondary passageway 44 in endotracheal tube 30 has beeneliminated.

As best shown in FIGS. 22A-22B, proximal end (cylindrical) region 39 ofa length of the endotracheal tube 30 may be flared such that it has agreater outer diameter than the remaining distal region of the length ofthe endotracheal tube 30. In such a manner, the outer diameter of thedistal region of the length of the endotracheal tube 30 may change inaccordance with different sized endotracheal tubes 30 (to accommodatepatients of different sizes such as pediatric, adolescent, adult) whilethe outer diameter of the proximal end (cylindrical) region 39 of theendotracheal tubes 30 may remain constant as to attach to a universallysized hub connection fitting 70.

In addition to the foregoing, an endotracheal tube connector 190, whichis also shown in FIGS. 25A-25B, may be used to mechanically connect theendotracheal tube 30 to the hub connection fitting body 72. As shownendotracheal tube connector 190 comprises an annular disc 192 definingan aperture 194 and having a peripheral lip 196. Peripheral lip 196 isconfigured to mate with an interference fit within a circular recess 198formed in the distal end of hub connection fitting body 72.

As shown the diameter of aperture 194 is smaller than the outer diameterof the proximal (cylindrical) end region 39 of the endotracheal tube 30which is flared. As such, in the event the outer surface 34 of theproximal end (cylindrical) region 39 of the endotracheal tube 30 is notadequately connected to inner (cylindrical) surface 91 of the recess 92,the annular disc 192 will inhibit the endotracheal tube 30 fromseparating from the hub connection fitting body 72.

In certain embodiments, the endotracheal tube connector 190 may be colorcoded to the size of the endotracheal tubes 30. In other words, a firstcolor (e.g. blue) of the endotracheal tube connector 190 may be matchedto a first size (e.g. small) of the endotracheal tube 30; a second color(e.g. red) of the endotracheal tube connector 190 may be matched to asecond size (e.g. medium) of the endotracheal tube 30; a third color(e.g. green) of the endotracheal tube connector 190 may be matched to athird size (e.g. large) of the endotracheal tube 30; etc. In theforegoing manner, a clinician or other medical treatment personnel maybe quickly made aware of the size of the endotracheal tube apparatus 30so as to determine if the size is suitable for the patient.

While a preferred embodiment of the present invention(s) has beendescribed, it should be understood that various changes, adaptations andmodifications can be made therein without departing from the spirit ofthe invention(s) and the scope of the appended claims. The scope of theinvention(s) should, therefore, be determined not with reference to theabove description, but instead should be determined with reference tothe appended claims along with their full scope of equivalents.Furthermore, it should be understood that the appended claims do notnecessarily comprise the broadest scope of the invention(s) which theapplicant is entitled to claim, or the only manner(s) in which theinvention(s) may be claimed, or that all recited features are necessary.

LISTING OF REFERENCE CHARACTERS

-   2 medical system-   10 medical device-   20 tube apparatus-   24 fluid sampling port (carbon dioxide sampling port)-   26 drug delivery port-   28 cuff inflation port-   30 tube-   31 proximal end of tube-   32 outer cylindrical side wall-   32 a outer cylindrical side wall-   32 b outer cylindrical side wall-   33 distal end of tube-   34 outer surface of tube-   36 inner surface of tube-   38 ventilation passageway of tube-   39 proximal end region of tube-   40 proximal end opening of tube-   41 common longitudinal (center) axis of tube-   42 distal end opening of tube-   43 proximal (flared) end region of secondary passageway-   44 secondary passageway (fluid sampling passageway)-   46 secondary passageway (drug delivery passageway)-   48 secondary passageway (cuff inflation passageway)-   49 inflation cuff-   50 inflation cuff opening-   54 semi cylindrical side wall-   56 semi cylindrical side wall-   58 semi cylindrical side wall-   70 hub connection fitting-   72 hub connection fitting body-   74 proximal body portion-   76 distal body portion-   78 intermediate/middle body portion-   80 ventilation passageway-   82 annular lip/shoulder-   84 annular lip/shoulder-   86 annular lip/shoulder-   90 annular ring-   91 inner (cylindrical) surface-   92 recess-   94 secondary passageway-   95 side wall-   96 secondary passageway-   97 side wall-   98 secondary passageway-   99 side wall-   100 notch-   101 sealing composition-   104 male connector portion-   106 male connector portion-   108 male connector portion-   114 counter-bore-   116 counter-bore-   118 counter-bore-   124 tubing segment-   126 tubing segment-   128 tubing segment-   134 passageway (lumen)-   136 passageway (lumen)-   138 passageway (lumen)-   142 filter-   143 colorimetric paper-   144 fluid sampling port threaded connector-   146 drug delivery port connector-   148 cuff inflation port connector-   158 light-source module receptacle-   159 aperture-   160 lighting apparatus-   161 reflective surface-   162 light-emitting device-   163 light-source module-   164 lighting device-   165 lamp/light source-   166 electrical conductor-   167 printed circuit board-   168 power source (battery)-   169 battery holder-   170 non-conductive liner-   171 elongated aperture-   172 pull tab of non-conductive liner-   173 elbow-   174 housing-   175 housing cavity-   176 light reflective surface-   177 wall of hub connection fitting body-   178 tubular light guide-   179 proximal end of tubular light guide-   180 distal end of tubular light guide-   181 gap-   182 plug-   183 plug body-   184 plug body recess-   185 through-hole-   186 injection port-   187 bushing-   190 endotracheal tube connector-   192 annular disc-   194 aperture-   196 peripheral lip-   198 circular recess-   200 sensor apparatus-   202 sensor-   204 sensor module-   206 sensor module receptacle-   210 infrared emitter-   212 infrared light source-   218 interference filter-   220 infrared detector-   230 processor-   240 non-transitory computer-readable storage medium-   250 communication element-   260 sensor output display-   500 respirator apparatus (bag valve mask)-   502 respirator tube passageway-   504 respirator tube-   506 respirator tube side wall-   600 analyzing/monitoring apparatus-   650 syringe-   700 drug delivery device-   800 cuff inflation device-   900 remote electronic device

What is claimed is:
 1. An endotracheal tube apparatus having a proximalend and a distal end, and further comprising: an endotracheal tubehaving a proximal end and a distal end; a hub connection fittingconnected to the endotracheal tube, the hub connection fitting disposedadjacent the proximal end of the endotracheal tube proximal to theproximal end of the endotracheal tube; the endotracheal tube configuredto be inserted into a trachea of a human body; a ventilation passagewaydisposed in the hub connection fitting and along a length of theendotracheal tube; a cuff inflation passageway disposed in the hubconnection fitting and the endotracheal tube; a light emitting devicecomprising a light source and a tubular light guide, the light sourceand the tubular light guide arranged such that light, when emitted fromthe light source, is transmitted along a longitudinal axis of thetubular light guide; the light source disposed in the hub connectionfitting; and the tubular light guide disposed in the endotracheal tubewithin the cuff inflation passageway.
 2. The endotracheal tube apparatusof claim 1 wherein: the hub connection fitting comprises a hubconnection fitting body; the light emitting device comprises alight-source module; and the light source module is contained in the hubconnection fitting body.
 3. The endotracheal tube apparatus of claim 2wherein: the light source module comprises at least one light-emittingdiode mounted to a printed circuit board, and a battery.
 4. Theendotracheal tube apparatus of claim 3 wherein: the light source modulecomprises a housing which contains the battery, and the printed circuitboard; and the housing is contained in the hub connection fitting body.5. The endotracheal tube apparatus of claim 1, wherein: the hubconnection fitting has a proximal connector portion and a distalconnector portion.
 6. The endotracheal tube apparatus of claim 5,wherein: the proximal connector portion and the distal connector portionare provided by a single body.
 7. The endotracheal tube apparatus ofclaim 5, wherein: the proximal connector portion is configured to beconnected to a respirator tube.
 8. The endotracheal tube apparatus ofclaim 5, wherein: the proximal connector portion is a male connectorportion.
 9. The endotracheal tube apparatus of claim 5, wherein: theproximal connector portion is cylindrical.
 10. The endotracheal tubeapparatus of claim 5, wherein: the distal connector portion is connectedto the endotracheal tube.
 11. The endotracheal tube apparatus of claim1, further comprising: a cuff inflation port in fluid communication withthe cuff inflation passageway.
 12. The endotracheal tube apparatus ofclaim 1, further comprising: the cuff inflation passageway extendsthrough the hub connection fitting.
 13. The endotracheal tube apparatusof claim 1, wherein: a cuff inflation port in fluid communication withthe cuff inflation passageway, the cuff inflation port joined to the hubconnection fitting by a tubing segment.
 14. The endotracheal tubeapparatus of claim 1, wherein: the tubular light guide is fixed inposition relative to the hub connection fitting by a composition. 15.The endotracheal tube apparatus of claim 14, wherein: the compositioncomprises at least one of a polymer, adhesive or potting resin.
 16. Theendotracheal tube apparatus of claim 1, wherein: a distal end of thecuff inflation passageway is sealed with a plug.
 17. The endotrachealtube apparatus of claim 16, wherein: the plug is light transmissive. 18.The endotracheal tube apparatus of claim 16, wherein: the tubular lightguide terminates in the cuff inflation passageway prior to the plug. 19.The endotracheal tube apparatus of claim 16, wherein: the tubular lightguide terminates within the plug.
 20. The endotracheal tube apparatus ofclaim 16, wherein: the tubular light guide extends through the plug. 21.The endotracheal tube apparatus of claim 1, wherein: the tubular lightguide comprises at least one optical fiber.
 22. The endotracheal tubeapparatus of claim 1, wherein: the tubular light guide has a diameter ina range of 0.1 mm to 2 mm.
 23. The endotracheal tube apparatus of claim1, wherein: the tubular light guide is formed of at least of a polymeror glass.
 24. The endotracheal tube apparatus of claim 1, wherein: thetubular light guide as a proximal end; and the proximal end of thetubular light guide is disposed in the hub connection fitting.
 25. Theendotracheal tube apparatus of claim 1, wherein: the tubular light guideas a distal end; and the distal end of the tubular light guide isdisposed in the endotracheal tube.
 26. The endotracheal tube apparatusof claim 1, wherein: the light source is disposed proximally adjacent aproximal end of the tubular light guide.
 27. The endotracheal tubeapparatus of claim 1, further comprising: an inflation cuff arranged tobe inflatable by transmitting a fluid through the cuff inflationpassageway; and the inflation cuff joined to the endotracheal tube.